[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"statin-adverse-reaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:statin-adverse-reaction":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,78,105,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100583274","phase-1-safety-and-efficacy-of-low-dose-colchicine-in-patients-with-statin-intolerance-the-lodoco-stint-pilot-study-100583274",false,"NCT06874192","Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study","Inclusion Criteria:\n\n* History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction\n* Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month\n* Patients able to provide informed consent.\n* Aged 18 to 80 will be enrolled in the study.\n\nExclusion Criteria:\n\n* Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.\n* Renal impairment (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2)\n* Transaminitis (ALT or AST \\>3 times upper limit of normal)\n* Cirrhosis\n* Severe Heart Failure\n* Active cancer or currently on chemotherapy\n* Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies\n* Active infection\n* Autoimmune or inflammatory condition\n* Pregnancy or breastfeeding.","ALL","18 Years","80 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.",[26],"Statin Adverse Reaction",[28],"statin intolerance","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2025-03-12",{"date":37,"type":20},"2026-08-30",{"name":39,"class":40},"Virginia Commonwealth University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":41},"100636266","exercise-intensity-and-muscle-recovery-in-statin-users-100636266","NCT07563452","Exercise Intensity and Muscle Recovery in Statin Users","Investigating the Role of Mechanical Muscle Loading in the Context of Preventive Exercise for Statin Users - a Pilot Study","STN-EX","Inclusion Criteria:\n\n* Sedentary behavior (defined as \\\u003C 1 hour of planned physical activity per week)\n* Low occupational physical activity\n* Age between 30 and 65 years\n* Non-smoker\n* Medical clearance to partake in physical exercise (as determined during screening visit)\n* For statin users: Current statin medication with stable dosage for at least 8 weeks prior to enrollment\n* For controls: Statin-naïve individuals\n\nExclusion Criteria:\n\n* BMI \\\u003C 20 kg\u002Fm² or \\> 30 kg\u002Fm²\n* Smoking or smoking cessation \\\u003C 1 year ago\n* Medical conditions or musculoskeletal issues that preclude eligibility for full physical effort or interfere with outcome measures\n* Medication (other than statins) that may interfere with physical exercise or outcome measures (assessment on a case-by-case basis during screening visit)\n* Any condition identified during screening (e.g., abnormal ECG, cardiopulmonary exercise test) that, in the opinion of the physician, precludes safe participation",true,"30 Years","65 Years",{"count":54,"type":20},40,[56],"NA","This study aims to investigate how different types and intensities of exercise affect muscle recovery in individuals taking statin medications compared to healthy controls. Statins are essential for cardiovascular prevention but are often associated with muscle-related side effects (SAMS), which can be exacerbated by physical activity.\n\nThe study will compare aerobic cycling (low muscular strain) with resistance training (RT) at increasing intensities (40%, 60%, and 80% of estimated 1-repetition maximum; e1RM). Researchers will measure markers of muscle damage, such as creatine kinase (CK) levels, and subjective recovery needs to determine which exercise modalities and intensities are best tolerated by statin users. The goal is to provide evidence for more individualized and safer exercise recommendations for this population.",[26],[60,61,62,63,64,65,66,67,68],"Statin","Statin-associated muscle symptoms","SAMS","Resistance training","Endurance training","Muscle loading","Creatine kinase","Recovery need","Exercise intensity","2026-06-19",{"date":71,"type":33},"2026-06-24",{"date":73,"type":33},"2026-06-08",{"date":75,"type":20},"2027-06",{"name":77,"class":40},"Raffaele Mazzolari",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":15,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100400870","phase-4-low-dose-rosuvastatin-plus-ezetimibe-versus-high-dose-rosuvastatin-in-ami-100400870","NCT04499859","Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI","A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention","ROSUZET-AMI","Inclusion Criteria:\n\n1. Adults Aged 19 and up\n2. Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)\n3. For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test\n4. Patients who agreed and signed on the informed consent form\n\nExclusion Criteria:\n\n1. Patients with life expectancy of a year or less due to malignancy\n2. Patients with chronic liver disease\n3. Patients with sensitivity to active ingredient of the research drugs (ezetimibe and\u002For rosuvastatin) or patients who are prohibited to take ezetimibe and\u002For rosuvastatin.\n4. Pregnant and\u002For breastfeeding\n5. Female patients who are unable to use any means of contraception\n6. Patients receiving hemodialysis, peritoneal dialysis patients and\u002For kidney transplant patients, due to end stage renal disease\n7. Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)\n8. Patients considered inappropriate for the study for any other reason(s) by the inspector(s)","19 Years",{"count":88,"type":20},3548,[90],"PHASE4","Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.\n\nThis trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.",[93,26,94],"Myocardial Infarction","HMG-CoA Reductase Inhibitor Toxicity","2025-07-28",{"date":97,"type":33},"2025-07-30",{"date":99,"type":33},"2020-10-01",{"date":101,"type":20},"2027-08-30",{"name":103,"class":40},"Kiyuk Chang, MD,PhD",7,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":15,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":41},"100577952","phase-4-desifor-expand-mhif-100577952","NCT06804980","DESIFOR-EXPAND (MHIF)","The DEterminig Statin Intolerance for Rosuvastatin Trial","Inclusion Criteria:\n\n* Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged.\n* 2\\. At least 30 days since discontinued use of a statin\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing or attempting to become pregnant\n* Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis\n* Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg","21 Years",{"count":114,"type":20},100,[90],"The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance",[118,26,60],"Statin Therapy",[120,121,122,123],"Statin Intolerance","lipid-lowering medication","LDL","LDL Cholesterol","2025-01-28",{"date":126,"type":33},"2025-02-03",{"date":128,"type":20},"2025-02-01",{"date":130,"type":20},"2026-12-31",{"name":132,"class":40},"Minneapolis Heart Institute Foundation",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":41},"100561594","hepatic-safety-of-statin-use-in-neurology-inpatients-100561594","NCT06592196","Hepatic Safety of Statin Use in Neurology Inpatients","A Retrospective Study on the Hepatic Safety of Statin Use in Neurology Inpatients","Inclusion Criteria:\n\n1. Patients hospitalized in the Department of Neurology of Yueyang Hospital from June 2020 to February 2023.\n2. Age ≥18 and ≤85 years old, both sexes.\n3. Meet the diagnostic criteria of cerebrovascular disease (L1-8B0), headache disease (L1-8A8) and dizziness and vertigo (MB48) in ICD-11.\n\nExclusion Criteria:\n\n1. Incomplete medical history.\n2. 1 days ≤ patients with \\\u003C 7 days of prior statin use.\n3. Patients with malignant tumors (ICD-11 code L1-2A0, L1-2A2, L1-2B5, L1-2E6 diseases) and hematological diseases (ICD-11 code L1-3A0, L1-3B1, L1-3B8 diseases).","85 Years",{"count":142,"type":20},2000,"OBSERVATIONAL","This research employs a cross-sectional study and a retrospective cohort study to analyze the liver safety of statin use among inpatients in the neurology department in China from different perspectives. The aim is to supplement evidence-based medicine and provide guidance for the clinical use of statins.",[26],"2024-09-11",{"date":148,"type":33},"2024-09-19",{"date":150,"type":33},"2024-08-10",{"date":152,"type":20},"2024-12-10",{"name":154,"class":40},"Shanghai Yueyang Integrated Medicine Hospital"]