FindTrial
Sign In

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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006806
Enrollment
1152
Registered
2021-12-03
Start date
2023-01-09
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Intervention: 3-month treatment of atorvastatin 10mg or higher, once daily, per oral or per nasogastric tube, for 3 months Control: no statin therapy for 3 months

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
composite event (stroke recurrence, myocardial infaraction, all-cause death)—

Secondary

MeasureTime frame
intracranial hemorrhage or symptomatic hemorrhagic transformation—

Countries

Korea, Republic of

Contacts

Public ContactSEUNG HEE LEE

Seoul National University Bundang Hospital

butteri1004@gmail.com+82-31-787-8307

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026