Statin therapy on prevention for composite event outcome (stroke recurrence, myocardial infarction, or all-cause death) in acute cardioembolic stroke patients with no definite indication for statin: A registry-based randomized controlled trial
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006806
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1152
1. Patients with ischemic stroke or transient ischemic attack confirmed by neuroimaging study
2. 19 years old or older
3. known or newly-documented high-risk cardioembolic source
High-risk cardioembolic sources: atrial fibrillation, atrial flutter, mechanical prosthetic valve, left atrial or atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy
4. no use of statin prior to the index stroke
5. no statin benefit group
- statin benefit groups
? Clinical atherosclerotic cardiovascular disease (ASCVD): Acute coronary
syndrome, history of myocardial infarction, stable or unstable angina or
coronary or other arterial revascularization, stroke transient ischemic attack, or peripheral artery disease, aortic aneurysm, all of atherosclerotic origin
? Age 20-75y & Low density lipoprotein-cholesterol (LDL-C) =190mg/dl
? Age 40-75y & Diabetes & LDL-C 70-189mg/dl
? Age 40-75 & no diabetes & LDL-C 70-189mg/dl & 10y ASCVD risk =7.5%
6. patients signed informed consent
1. abnormal liver function test (AST or ALT> 200 IU/L)
2. allergy or contraindication for statin
3. pregnancy or breast-feeding
4. participation to other randomized trial regarding drug for dyslipidemia
5. life expectancy - less than 6 months
6. taking prohibited medications
? other statin
? PCSK-9 inhibitor
? cyclosporin
? fenofibrate
? other drugs that might influence the efficacy of intervention drug
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite event (stroke recurrence, myocardial infaraction, all-cause death)
- Secondary Outcome Measures
Name Time Method intracranial hemorrhage or symptomatic hemorrhagic transformation