RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - (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. Who Should NOT Join This Trial: - (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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * (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 Criteria: * (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.

Treatments Being Tested

DRUG

statin + ezetimibe

Moderate-intensity statin plus ezetimibe 10mg

DRUG

Statin monotherapy (rosuvastatin or atorvastatin)

Moderate- or high-intensity statin monotherapy

Locations (1)

Chang Gung Memorial Hospital, Chiayi Branch

Pozi, Taiwan