[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anticoagulant-adverse-reaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anticoagulant-adverse-reaction":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,52,82,106,132,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100522161","cooley--study-acute-on-chronic-liver-failure-using-the-cytosorb-device-100522161",false,"NCT06079021","COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device","COOLEY","Inclusion Criteria:\n\n* adult patients (≥ 18 years) admitted to the University Hospital of Antwerp (UZA), Belgium.\n\n  * Written informed consent from patient or if not possible due to encephalopathy (\\> grade 2): legal representative\n  * acute-on-chronic liver failure (ACLF) grade ≥ 2:\n\n    * Acute decompensation event (identifiable trigger)\n    * Hepatic encephalopathy grade ≥ 2\n    * Acute kidney injury (AKI) according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (≥ 3-fold increase of serum creatinine OR increase of serum creatinine to ≥ 4 mg\u002Fdl OR urine output ≤ 0.3 ml\u002Fkg\u002Fh for ≥ 24 hours OR anuria for ≥ 12 hours)\n    * Serum bilirubin ≥ 10 mg\u002Fdl\n    * Hemodynamic instability with vasopressor support (norepinephrine \\> 0.05 mcg\u002Fkg\u002Fmin)\n\nExclusion Criteria:\n\n* • known patient will against participation in the study or against the measures applied in the study\n\n  * a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours\n  * no complete remission of malignancy including hepatocellular carcinoma within the past 12 months\n  * ongoing intermittent or CRRT before study inclusion","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.",[26,27,28,29],"Acute-On-Chronic Liver Failure","Anticoagulant Adverse Reaction","Sarcopenia","Ultrasonography",[31,32,33,34,35,36,37,38],"acute on chronic liver failure","sarcopenia","citrate anticoagulation","low molecular weight heparins","hand grip strength","skeletal muscle ultrasound","hemoadsorption","CRRT","RECRUITING","2026-04-27",{"date":42,"type":43},"2026-05-01","ACTUAL",{"date":45,"type":43},"2024-06-08",{"date":47,"type":20},"2027-12-31",{"name":49,"class":50},"University Hospital, Antwerp","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":51},"100308589","stop-or-ongoing-oral-anticoagulation-in-patients-undergoing-pvp-soap-100308589","NCT03297281","Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)","Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization","SOAP","Inclusion Criteria:\n\n* Prostate volume \\\u003C or = 30 gr\n* Micturition disorders resistant to medical treatment related to HBP and\u002For complications related to BPH (retention, lithiasis...)\n* Patient candidate for photovaporization of the prostate\n* Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months\n* Unprotected major\n* Patient affiliated to a social security scheme or equivalent\n* Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form.\n\nExclusion Criteria:\n\n* History of prostate cancer\n* Previous pelvic radiotherapy\n* History of stenosis of the urethra\n* Patient with one or more bladder polyps\n* Patient under antiplatelet agent other than aspirin\n* Allergy to heparin or history of heparin-induced thrombocytopenia\n* Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux)\n* Any mechanical prosthetic heart valve\n* Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks\n* Venous thromboembolism (deep vein thrombosis and\u002For pulmonary embolism) within past 12 weeks\n* Major bleeding within past 6 weeks\n* Severe renal insufficiency (calculated creatinine clearance \\\u003C 30 mL \u002F min)\n* Thrombocytopenia (platelet count \\\u003C 100 x 10\\^9 \u002F L)\n* Life expectancy \\\u003C 1 month\n* Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility)\n* Contra-indication to PVP surgery or contra-indication to general anesthesia\n* Protected patients : majors under some form of guardianship\n* Patient participating in another clinical study","MALE",{"count":62,"type":20},389,[23],"Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.\n\nFor benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new \"minimally invasive\" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.\n\nGiven the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.\n\nNumerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.\n\nNo study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.\n\nThis study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.",[66,27],"Benign Prostatic Hyperplasia",[68,69,70,71,72],"Photovaporization","Laser","Benign prostatic hyperplasia","Oral anticoagulation","Complication","2026-03-04",{"date":75,"type":43},"2026-03-06",{"date":77,"type":43},"2017-10-30",{"date":79,"type":20},"2028-05-31",{"name":81,"class":50},"Clinique Pasteur",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100405193","the-clinical-influence-of-developing-a-sustainable-cardiac-surgery-service-to-reduce-the-burden-of-rheumatic-heart-disease-in-sub-saharan-africa-100405193","NCT04556188","The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa","RHD-CaSS","Inclusion Criteria:\n\n* Cardiac surgery due to rheumatic heart disease at the governmental Black Lion University Hospital during the bi-directional programme of education, training and Research to establish Cardiac surgery service\n\nExclusion Criteria:\n\n* Not willing or able to provide written informed consent","14 Years",{"count":91,"type":20},200,"OBSERVATIONAL","In this bi-directional program of education, training and research activities based on sustainable development goals aim is to develop cardiac surgery service in Ethiopia.\n\nThe aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service. Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country .",[95,27],"Rheumatic Heart Disease","2025-06-11",{"date":98,"type":43},"2025-06-12",{"date":100,"type":43},"2016-03-01",{"date":102,"type":20},"2026-06-30",{"name":104,"class":50},"Helse Nord-Trøndelag HF",4,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":129,"locationsCount":51},"100524414","phase-4-low-dose-versus-standard-dose-rivaroxaban-in-elderly-patients-with-atrial-fibrillation-100524414","NCT06108414","Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation","The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation","Inclusion criteria:\n\n* Age ≥70 years\n* Patients with atrial fibrillation (atrial fibrillation rhythm of at least 30 seconds duration recorded by ECG or Holter within 1 year)\n* CHA2DS2-VASc score ≥2 in men and ≥3 in women\n* Able to cooperate in signing ICFs\n\nExclusion criteria：\n\n* Moderate-to-severe mitral stenosis, or prior mechanical valve replacement surgery, or unresected atrial myxoma, or known left ventricular thrombus\n* Prior biological valve replacement or valve repair surgery within 6 months\n* Left ventricular assist device implantation status\n* Severe stroke event within 3 months or any stroke within 14 days Major stroke events were defined as those with a Modified Rankin Scale score of 3-5.\n\nScore 3: moderately disabled, requiring some assistance but walking without assistance; Score 4: severe disability, unable to walk independently, unable to meet their own needs without the help of others; Score 5: severe disability, bedridden, incontinent, requiring ongoing care and attention\n\n* Transient ischemic attack (TIA) occurred within 3 days\n* Transient atrial fibrillation due to reversible triggers (e.g., after cardiac surgery, pulmonary embolism, untreated hyperthyroidism)\n* Prior or planning to undergo atrial fibrillation catheter ablation, drug cardioversion, electroconversion, or major surgery in 3 months; Prior catheter or surgical ablation \\> 3 months without atrial fibrillation electrocardiogram records\n* Prior or planning to undergo left atrial appendage occlusion\n* Active infective endocarditis\n* High or increasing risk for bleeding i. Traumatic surgery that has been completed within the last 3 months or is planned within the next 3 months ii. Previous severe intracranial, intraocular, spinal cord, retroperitoneal, or nontraumatic intra-articular hemorrhage.\n\niii. Gastrointestinal bleeding within the past year iv. Symptomatic or gastroscopic peptic ulcer within the last month v. Hemorrhagic constitution or coagulopathy vi. Difficult-controlled hypertension (180mm Hg systolic and\u002For 100 mm Hg diastolic)\n\n* Severe renal impairment (estimated creatinine clearance ≤ 15 mL\u002Fmin)\n* Active liver disease\n\nIncluding but not limited to:\n\ni. Persistent ALT, AST \\> 2×ULN; ii. TBil \\> 1.5×ULN; iii. Known active hepatitis A, B or C; iv. Cirrhosis\n\n* Hemoglobin level \\\u003C100g\u002FL or thrombocytopenia count \\\u003C100 × 10\\^9\u002FL\n* Having conditions warrant standard-dose or low-dose anticoagulation treatment (non-AF, such as VTE)\n* Having conditions warrant warfarin anticoagulation treatment\n* Daily dose of aspirin \\>100mg\n* Having received dual antiplatelet therapy or intravenous antiplatelet drugs within 5 days (note: P2Y12 receptor antagonist alone or ≤ 100mg aspirin alone can be enrolled)\n* Having received fibrinolysis treatment in 10 days or planning to use fibrinolytic drugs\n* Having conditions warrant the following medications: CYP3A4 and P-gp inhibitors (itraconazole, ketoconazole, voriconazole, posaconazole, clarithromycin, erythromycin, fluconazole, ritonavir, dronedarone, etc.), selective serotonin reuptake inhibitors (SSRI)\u002Fserotonin norepinephrine reuptake inhibitors (SNRI) drugs (fluoxetine, paroxelin, etc.) CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort, etc.), long-term use of NSAIDs\n* Having allergic or adverse reactions to any excipients (including but not limited to lactose, starch, etc.) in rivaroxaban tablets, including but not limited to hereditary lactose or galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.\n* Having diagnosed with malignant tumors within 6 months, or receiving radiotherapy\u002Fchemotherapy, with an expected lifespan of no more than 3 years\n* Antiphospholipid syndrome\n* Having been enrolled in another interventional clinical trial within the past 30 days or at the same time\n* Mental disorders, communication barriers, cognitive impairment, or other serious illnesses that may affect the participation in this study\n* Known poor adherence to study follow-up or taking study drugs\n* Other conditions deemed by the investigator to be inappropriate for enrollment","70 Years",{"count":115,"type":20},4374,[117],"PHASE4","To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.",[120,27,121,122],"Atrial Fibrillation","Stroke","Major Adverse Cardiac Events","2024-09-11",{"date":125,"type":43},"2024-09-19",{"date":127,"type":43},"2024-09-01",{"date":47,"type":20},{"name":130,"class":131},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":5},"100546949","phase-4-can-patients-with-atrial-fibrillation-safely-discontinue-anticoagulant-therapy-after-cardiac-surgery-atlaac-100546949","NCT06401616","Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)","Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)","Inclusion Criteria:\n\n* Age \\> 18 years\n* Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project.\n* Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record\n* Informed consent\n\nExclusion Criteria:\n\n* Not receiving OAC (warfarin\u002FDOAC)\n* Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism)\n* Renal impairment (estimated glomerular filtration rate \\\u003C 30)\n* Allergy to contrast media\n* Pregnancy or breastfeeding",{"count":140,"type":20},1220,[117],"Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed.\n\nThe ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention",[120,144,27],"Left Atrial Appendage Absent",[146,147,148,149],"Atrial fibrillation","Anticoagulant treatment","Surgical left atrial appendage closure","surgical left atrial appendage occlusion","2024-05-22",{"date":152,"type":43},"2024-05-23",{"date":154,"type":43},"2024-05-21",{"date":156,"type":20},"2028-03",{"name":158,"class":50},"Odense University Hospital",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":51},"100530479","phase-4-clinical-trial-to-evaluate-efficacy-and-safety-of-rivaroxaban-15mg-and-20mg-in-patients-with-non-valvular-atrial-fibrillation-100530479","NCT06187311","Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation","A Randomized, Open-labelled, Investigator-initiated Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation","REVISE-AF","Inclusion Criteria:\n\n1. adult men and women over 19 years of age when screening\n2. A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.\n3. Anticoagulants for the prevention of stroke or systemic embolism For cases where medication is required, a person with a CHA2DS2-VASC score of 1 male\u002Ffemale 2 or more points (In case of one or more risk factors)\n4. 4\\) CrCl (Creatinine Clearance) ≥50 ml\u002Fmin\n5. A person who voluntarily agrees in writing to this study\n\nExclusion Criteria:\n\n1. Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve\n2. Thyroid disease, terminal hypertrophy, brown cytoplasm, adrenal glands that affect the occurrence of atrial fibrillation A person accompanied by cortical disease, parathyroid disease, pancreatic disease, etc.\n3. clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)\n4. Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding\n5. Patients with increased risk of bleeding due to the following conditions:\n\n   * Gastrointestinal ulcer history within 6 months prior to random allocation\n\n     * Intracranial or intracranial hemorrhage history within 6 months prior to random assignment\n\n       * vascular abnormalities in the spinal cord or brain\n\n         * History of brain, spinal cord or ophthalmic surgery within 30 days prior to random assignment\n\n           ⑤ Brain or spinal cord injury within 6 months prior to random allocation\n\n           ⑥ If you have esophageal varices or are suspected\n\n           ⑦ Arteriovenous malformations\n\n           ⑧ Vascular aneurysms\n\n           ⑨ Patients with malignant tumors (Neoplasm) at high risk of bleeding\n6. Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks\n7. Patients who are overreacting to the main or components of Rivaroxaban\n8. Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability\n9. Patients with uncontrolled hypertension (systolic BP \\> 180 mm Hg or diastolic BP \\> 100 mm Hg)","19 Years","99 Years",{"count":170,"type":20},940,[117],"In this clinical trial, Rivaroxaban of standard dose (20mg) and reduced dose (15mg) will be administeted in non-valvular atrial fibrillation patients without severe renal dysfunction.\n\nIt is a randomized, open-label, and phase 4 clinical trial to compare and evaluate efficacy and safety of Rivaroxaban.\n\nAfter obtaining informed consent to participate in this trial, screening is performed (Screening visit).\n\nScreening includes baseline 12-lead electrocardiography and laboratory tests to exclude severe end-organ dysfunction (such as renal dysfunction, liver dysfunction, or anemia).\n\nBaseline visits are available on the same day. After screening, subjects eligible for the trial will be randomly assigned (1:1 ratio) to Group 1 (15 mg of Rivaroxaban) or Group 2 (20 mg of Rivaroxaban) (Baseline visit).\n\nThe study drug (Rivaroxaban 15mg or 20mg daily) will be administered for 12 months.\n\nDuring study period, a total of six visits (3,6,9,12 months) will be made, and follow-up test and outcome measurement will be done in each visit.",[120,27],[175,176],"Non-vitamin K antagonist oral anticoagulant","rivaroxaban","2023-12-31",{"date":179,"type":43},"2024-01-05",{"date":181,"type":43},"2023-01-12",{"date":183,"type":20},"2027-06-30",{"name":185,"class":50},"Korea University Anam Hospital"]