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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

Not Applicable
Recruiting
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
composite event (stroke recurrence, myocardial infaraction, all-cause death)
Secondary Outcome Measures
NameTimeMethod
intracranial hemorrhage or symptomatic hemorrhagic transformation
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