[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colchicine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colchicine":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,70,95,121,143,168,193,217],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100620849","phase-4-precision-colchicine-intervention-to-suppress-atherosclerosis-in-tet2-clonal-hematopoiesis-100620849",false,"NCT07362966","Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis","Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis : a Pilot Clinical Trial (PRECISE)","Inclusion Criteria:\n\n1. Age 40-85 years;\n2. Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following:\n\n   1. During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone,\n   2. At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography,\n   3. Clinically stable throughout the screening period,\n   4. Receiving standard of care therapy for ACS in accordance with national guidelines,\n   5. Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants;\n3. Written informed consent.\n\nExclusion Criteria:\n\n1. Prior coronary artery bypass grafting (CABG) before documented ACS;\n2. Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation;\n3. Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels \\\u003C1.5 mm in diameter) deemed to preclude plaque assessment by CCTA;\n4. Planned PCI or CABG;\n5. Abnormal liver function (ALT \\>3 times the upper limit of normal range) at randomization;\n6. Abnormal renal function (serum creatinine \\>1.5 times the upper limit of normal range or estimated eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²) at randomization;\n7. Hematologic abnormalities: anemia (hemoglobin \\\u003C100g\u002FL), thrombocytopenia (platelet count \\\u003C100×109\u002FL) or leukopenia (white blood cell \\\u003C3×109\u002FL) at randomization;\n8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea;\n9. Symptomatic peripheral neuropathy, pre-existing progressive neuromuscular disease or creatine kinase (CK) level \\> 3 times the upper limit of normal range as measured within the past 30 days and determined to be non-transient through repeat testing;\n10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception;\n11. Any contraindication, known allergy or intolerance to colchicine;\n12. Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications;\n13. Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics;\n14. Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;\n15. History of malignancy (hematologic or solid-tumor);\n16. History of transplantation (hematopoietic stem cell or solid-organ);\n17. Significant radiation exposure (≥40 mSv) within the past 12 months;\n18. Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism;\n19. Current enrollment in another clinical trial;\n20. A predicted life expectancy \\\u003C 1 year;\n21. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.","ALL","40 Years","85 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study aims to investigate whether TET2-associated clonal hematopoiesis of indeterminate potential (TET2-CHIP) can serve as a biomarker to guide precision use of colchicine in a population of clinically stable post-ACS patients receiving standard of care (SoC) therapy. Specifically, we will evaluate whether TET2-CHIP status predicts a differential response to colchicine. As a pilot study, it also aims to provide detailed data supporting design of further trial, such as sample size calculating, endpoint optimizing, etc.",[27,28,29],"Colchicine","Coronary Atherosclerosis Management","Clonal Hematopoiesis of Indeterminate Potential","RECRUITING","2026-06-28",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2026-06-08",{"date":38,"type":21},"2027-12-01",{"name":40,"class":41},"Shenyang Northern Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":42},"100615034","phase-4-colchicines-effect-on-inflammatory-markers-100615034","NCT07287345","Colchicine's Effect on Inflammatory Markers","Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study","Inclusion Criteria:\n\n* Age 18 years and older\n* Coronary artery bypass graft (CABG) planned procedure\n\nExclusion Criteria:\n\n* History of atrial fibrillation\n* Off-pump CABG procedure\n* Current treatment with colchicine for any cause\n* Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever)\n* Emergency cardiac surgery\n* Extracorporeal Membrane Oxygenation (ECMO) pre- or post-cardiac surgery\n* Heart transplant patients\n* Left ventricular assist device (LVAD) patients\n* Serum creatinine \\>2.0 mg\u002FdL\n* Preoperative elevated CK or known myopathy\n* Severe liver disease or elevation of serum transaminases (\\>1.5 times the upper limit of 40 units\u002Fliter)\n* Chronic intestinal disease or blood dyscrasia\n* Unable to speak English\n* Pregnancy or lactation in women","18 Years","99 Years",{"count":53,"type":21},24,[24],"This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.",[27,57,58,59,60],"Inflammation in Cardiac Surgery","Post Operative Atrial Fibrillation","Inflammatory Markers","Colchicine Adverse Reaction","2026-06-23",{"date":63,"type":34},"2026-06-25",{"date":65,"type":34},"2026-01-16",{"date":67,"type":21},"2026-12-30",{"name":69,"class":41},"Ayesha Ather",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":42},"100636718","low-dose-colchicine-for-cabg-graft-failure-prevention-100636718","NCT07569328","Low-dose Colchicine for CABG Graft Failure Prevention","Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Be male or female, aged 18 years or older;\n2. Within 3 days after successful isolated coronary artery bypass grafting (CABG);\n3. Sign informed consent;\n\nExclusion Criteria:\n\n1. Severe valvular heart disease requiring concomitant or staged valvular surgery;\n2. History of non-skin cancer in the past 3 years;\n3. Inflammatory bowel disease or chronic diarrhea;\n4. Neuromuscular diseases or non-transient creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);\n5. Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities (Hemoglobin \\\u003C100g\u002FL or hematocrit \\\u003C 30% or \\> 52% or white blood cell count \\\u003C 3×109\u002FL or platelet count \\\u003C 100×109\u002FL);\n6. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² (based on the CKDEPI formula);\n7. Serum alanine aminotransferase and\u002For aspartate aminotransferase levels greater than 2 times the upper limit of the normal range, accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders (INR\\>1.5) (except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);\n8. Decline in cognitive function due to inability to perform basic activities of daily living independently;\n9. Drug or alcohol abuse;\n10. Other immunosuppressive therapies already in existence or planned;\n11. Other causes require long-term colchicine treatment;\n12. History of clear or suspected colchicine allergy;\n13. Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.",{"count":78,"type":21},622,[80],"NA","This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.",[83,84,27],"CAD - Coronary Artery Disease","CABG","NOT_YET_RECRUITING","2026-04-29",{"date":88,"type":34},"2026-05-06",{"date":90,"type":21},"2026-09-01",{"date":92,"type":21},"2029-09-01",{"name":94,"class":41},"Beijing Anzhen Hospital",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100561251","phase-3-colchicine-for-the-reduction-of-dependency-and-vascular-events-after-an-acute-intracerebral-hemorrhage-100561251","NCT06587737","Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage","A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis","CoVasc-ICH2","Inclusion Criteria:\n\nAdult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:\n\ni. history of symptomatic coronary, peripheral and\u002For carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical\u002Fintracranial atherosclerotic disease causing any degree of stenosis\u002Focclusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (eGFR: 15-50mL\u002Fmin), history of ischemic stroke or current smoking (mild atherosclerotic vascular disease).\n\nExclusion Criteria:\n\n* secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)\n* ICH volume more than 60ml in the last imaging scan prior to consent\n* Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent\n* inflammatory bowel disease or chronic diarrhea\n* cirrhosis or severe hepatic dysfunction\n* renal insufficiency (eGFR\\\u003C15mL\u002Fmin)\n* concurrent or planned treatment with strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir\u002Fritonavir, indinavir, itraconazole, ketoconazole, lopinavir\u002Fritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir\u002Fritonavir) or P-gp inhibitors (cyclosporine, ranolazine)\n* pregnancy or breast-feeding\n* known allergy or sensitivity to colchicine\n* a strong indication for colchicine where assignment to placebo is deemed unacceptable\n* estimated life expectancy less than 6 months at the time of enrollment, and\n* inability to adhere to study procedures",{"count":104,"type":21},1125,[106],"PHASE3","Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors.\n\nThe objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.",[27,109,110,111],"ICH - Intracerebral Hemorrhage","Stroke","Dependence","2026-02-23",{"date":114,"type":34},"2026-02-25",{"date":116,"type":21},"2026-05-30",{"date":118,"type":21},"2028-10-30",{"name":120,"class":41},"Population Health Research Institute",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":42},"100577794","phase-4-pilot-trial-of-colchicine-for-graft-failure-in-cabg-100577794","NCT06802926","Pilot Trial of Colchicine for Graft Failure in CABG","A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG","CoCAB-Pilot","Inclusion Criteria:\n\n* Age≥18 years old，\n* Any sex，\n* Signed informed consent，\n* Within 3 days after a successful isolated CABG\n\nExclusion Criteria:\n\n* Allergy,\n* Hematopoietic dysfunction,\n* Moderate to severe hepatic dysfunction,\n* Moderate to severe renal dysfunction.",{"count":130,"type":21},100,[24],"The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG.\n\nThe main questions it aims to answer is:\n\n1. Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG.\n2. Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis.\n\nResearchers will compare colchicine to none to see if colchicine works.\n\nParticipants will\n\n1. Take oral colchicine (0.5mg daily) therapy for 12 months after CABG.\n2. Clinical follow-up at Month 1, 6, and 12 after CABG.\n3. Protocol-driven CCTA at Week 1 and Month 12 after CABG.",[84,134,27],"Graft Failure","2025-12-29",{"date":137,"type":34},"2026-01-02",{"date":135,"type":34},{"date":140,"type":21},"2028-12",{"name":142,"class":41},"Ruijin Hospital",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":42},"100577470","phase-4-the-effect-of-colchicine-on-the-occurrence-of-atrial-fibrillation-after-cardiac-surgery-100577470","NCT06798714","The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery","The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)","CAFE","Inclusion Criteria:\n\n1. Elective coronary artery bypass grafting on pump;\n2. signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Reduced left ventricular ejection fraction (≤35%);\n2. Valvular heart disease requiring surgical correction;\n3. Liver failure with an increase in liver transaminases ≥1.5 times;\n4. Renal failure (GFR\\\u003C35 mL\u002Fmin\u002F1.73 m2 calculated with CKD-EPI);\n5. Permanent, persistent or paroxysmal atrial fibrillation;\n6. Previously implanted pacemaker;\n7. Hypersensitivity to colchicine;\n8. Neutropenia;\n9. History of alcoholism;\n10. Refusal to sign informed consent",{"count":152,"type":21},140,[24],"Development of a new comprehensive method for perioperative prevention of atrial fibrillation paroxysms in cardiac surgery patients at the hospital stage.\n\nIt is planned to recruit 70 patients who will undergo pericardial fenestration during the operation using the original technique during coronary artery bypass grafting (Patent No. 2647626 C1 Russian Federation), and will be prescribed colchicine (the drug \"Colchicum-dispert\") in the perioperative period in order to prevent the development of paroxysms of atrial fibrillation in the postoperative period, and 70 cardiac surgery patients operated on using the standard technique (without performing the pericardial fenestration procedure intraoperatively), receiving non-steroidal anti-inflammatory drugs in the postoperative period.",[156,157,158,27],"Coronary Artery Disease","Atrial Fibrillation","Coronary Artery Bypass Grafting","2025-09-02",{"date":161,"type":34},"2025-09-09",{"date":163,"type":34},"2025-01-20",{"date":165,"type":21},"2026-02-20",{"name":167,"class":41},"Tomsk Cardiology Research Institute",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100552424","phase-3-efficacy-and-safety-of-colchicine-after-pci-100552424","NCT06472908","Efficacy and Safety of Colchicine After PCI","Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention","Inclusion Criteria:\n\n* (1) Capable and willing to provide informed consent;\n* (2) Age ≥18 and ≤80 years old, regardless of sex;\n* (3) Hospitalized patients with CHD requiring PCI;\n* (4) Completion of all planned PCI during hospitalization;\n* (5) Standardized treatment of coronary artery disease according to national guidelines.\n\nExclusion Criteria:\n\n* (1) Known allergy to colchicine;\n* (2) Colchicine taken within 10 days prior to randomization group;\n* (3) Patients currently in cardiogenic shock or hemodynamically unstable;\n* (4) Patients with known inflammatory bowel disease or chronic diarrhea;\n* (5) Abnormal liver function (ALT\\> 3 times the upper limit of normal);\n* (6) Abnormal renal function (eGFR\\\u003C30mL\u002Fmin\u002F1.73m2);\n* (7) Active malignant tumors reported in past medical history;\n* (8) Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;\n* (9) Pregnant women, lactating women or women of childbearing age who did not use effective contraceptives;\n* (10) Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.","80 Years",{"count":177,"type":21},8862,[106],"Colchicine (0.5 mg\u002Fday) was recommended by the U.S. Food and Drug Administration in 2023 for the anti-inflammatory treatment of coronary heart disease (CHD). However, colchicine is still not approved for CHD treatment in China. There is no large-scale clinical evidence that colchicine can be used to treat Chinese patients with CHD. Considering the low body weight of the East Asian population, it is unclear whether the recommended standard dose (0.5 mg\u002Fday) is suitable for Chinese patients. Therefore, we need to further explore the effects of different doses of colchicine on the efficacy and safety of clinical endpoints in the Chinese population with CHD.\n\nThis study is a multicenter, prospective, randomized, controlled, double-blind, event-driven clinical study conducted in China. The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI. The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population.",[181,182,27],"Coronary Heart Disease","Percutaneous Coronary Intervention","2025-03-25",{"date":185,"type":34},"2025-03-30",{"date":187,"type":34},"2024-07-09",{"date":189,"type":21},"2028-08-31",{"name":191,"class":41},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",36,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":42},"100532683","treatment-of-acute-coronary-syndromes-with-low-dose-colchicine-100532683","NCT06215989","Treatment of ACuTe Coronary Syndromes With Low-dose colchICine","Treatment of ACuTe Coronary Syndromes With Low-dose colchICine (TACTIC): a Randomised, Double-blinded, Placebo-controlled, Multicentric Trial","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Definite diagnosis of ACS;\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Type 2 myocardial infarction (Patients with symptoms or signs of myocardial ischemia and evidence of increased oxygen demand or decreased supply \\[for example, tachyarrhythmia, hypotension, or anaemia\\] secondary to an alternative pathology and myocardial necrosis are defined as suffering type 2 myocardial infarction. The classification of type 2 myocardial infarction also includes patients with coronary vasospasm, embolism or spontaneous dissection without evidence of atherothrombosis related to coronary artery disease);\n* Valvular heart disease that is considered likely to require surgical intervention;\n* History of non-skin cancer in the past 3 years;\n* Inflammatory bowel disease or chronic diarrhea;\n* History of gastric ulcer or previous gastric bleeding;\n* Neuromuscular diseases or non-transient (At least 2 laboratory tests) creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);\n* Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities(Hemoglobin \\\u003C100g\u002FL or hematocrit \\\u003C 30% or \\> 52% or white blood cell count \\\u003C 3×109\u002FL or platelet count \\\u003C 100×109\u002FL);\n* Estimated glomerular filtration rate (eGFR)\\\u003C30mL\u002Fmin\u002F1.73m2 (based on CKD-EPI formula);\n* Serum alanine aminotransferase and\u002For aspartate aminotransferase levels greater than 2 times the upper limit of the normal range accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders(INR\\>1.5)(except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);\n* Decline in cognitive function due to inability to perform basic activities of daily living independently;\n* Drug or alcohol abuse;\n* Other immunosuppressive therapies already in existence or planned;\n* Other causes require long-term colchicine treatment;\n* History of clear or suspected colchicine allergy;\n* Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.",{"count":201,"type":21},6574,[80],"This trial is designed to evaluate whether low-dose colchicine, in addition to standard treatment recommended by guidelines, further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.",[205,206,207,208,27],"Acute Coronary Syndrome","Unstable Angina","ST Elevation Myocardial Infarction","Non ST Segment Elevation Myocardial Infarction","2024-10-27",{"date":211,"type":34},"2024-10-30",{"date":213,"type":34},"2024-09-02",{"date":215,"type":21},"2028-06",{"name":94,"class":41},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":234,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":42},"100562549","phase-4-colchicine-in-patients-with-heart-failure-with-preserved-ejection-fraction-and-inflammation-100562549","NCT06604611","Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation","Efficacy and Safety of Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation","CHIPS","Inclusion Criteria:\n\n* Left ventricular ejection fraction measured by echocardiography ≥ 50%\n* Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g\u002Fm2 in female and ≥115 g\u002Fm2 in male or 2)LAVI greater than 29ml\u002Fm2 in sinus rhythm or greater than 40ml\u002Fm2 in atrial fibrillation or 3)Average E\u002Fe' greater than 14 or 4)TR velocity greater than 2.8 m\u002Fs\n* Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg\u002Fml in patients with sinus heart rate; ≥600 pg\u002Fml in patients with atrial fibrillation\n* Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV\n* Patients with CRP levels greater than 2mg\u002FL\n* Patient agrees to join and signs a written informed consent form\n\nExclusion Criteria:\n\n* Received colchicine treatment within one month prior to randomization\n* Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months\n* eGFR less than 25 mL\u002Fmin\u002F1.73 m2\n* Liver function Child-Pugh class B or C\n* Patient has a history of previous allergy to colchicine or dapagliflozin \u002F empagliflozin\n* Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease\n* Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors\n* Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures\n* Pregnant or breastfeeding women\n* The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician\n* Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6\n* Patient with combined active solid tumor or hematological malignancy\n* Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD\n* Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10\\*109\u002FL)\n* Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF",{"count":226,"type":21},200,[24],"The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.",[230,231,232,233,27],"Heart Failure","Heart Failure With Preserved Ejection Fraction (HFPEF)","Chronic Inflammation","Inflammation",[230,235,233],"Heart Failure with Preserved Ejection Fraction (HFpEF)","2024-09-17",{"date":238,"type":34},"2024-09-19",{"date":240,"type":21},"2024-10-31",{"date":242,"type":21},"2026-03-31",{"name":244,"class":41},"Dongying Zhang"]