RecruitingPhase 2NCT07307989

Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis

Early Statin-Ezetimibe Combination vs. Statin Monotherapy to Achieve LDL-C < 70 mg/dL in Recent Ischemic Stroke Patients With Evidence of Atherosclerosis: A Randomized Controlled Trial

Sponsor

Chang Gung Memorial Hospital

Enrollment

300 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke Hypercholesteremia

Summary

This study will be conducted at six medical institutions in Taiwan, recruiting patients who visit neurology outpatient clinics or are hospitalized within 30 days after an ischemic stroke. Participants will be randomly assigned to either the experimental group (moderate-intensity statin plus ezetimibe) or the control group (moderate- or high-intensity statin). Research assistants will screen patients aged 40 or older who have had an ischemic stroke or transient ischemic attack within 30 days, have atherosclerosis, and have LDL-C levels ≥100 mg/dL. Eligible cases will be reviewed by the attending physician. With physician approval, patients will be invited to join the study, and those who agree and sign informed consent will be enrolled.

Eligibility

Min Age: 20 YearsMax Age: 100 Years

Inclusion Criteria1

(1) clinical diagnosis of ischemic stroke or TIA; (2) Stroke or TIA symptoms and randomized within 30 days, then taking assigned medication within 2 days of randomization; (3) aged 20 years or older; (4) LDL-C ≥ 100 mg/dL after index ischemic stroke or TIA; (5) having evidence of atherosclerosis.

Exclusion Criteria1

(1) end stage renal disease because there is no clear benefit of LDL-C lowering therapy in these patients; (2) history of statin intolerance; (3) history of ezetimibe intolerance; or (4) ALT > 100 U/L.(5) Statins were regularly used before stroke. (6) Ezetimibe was used before stroke.

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