Early combined statin and ezetimibe treatment versus statin alone after ischemic 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

This study will test whether adding ezetimibe to a moderate-intensity statin soon after an ischemic stroke helps lower LDL cholesterol more than a statin alone in people with atherosclerosis and LDL-C ≥100 mg/dL.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 20 Years to 100 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (other)
• Locations: 1 site (Pozi)
• Trial ID: NCT07307989 on ClinicalTrials.gov

What this trial studies

Adults who had an ischemic stroke or TIA within 30 days, have evidence of atherosclerosis, and LDL-C ≥100 mg/dL will be randomized to receive either a moderate-intensity statin plus ezetimibe or a moderate- or high-intensity statin alone. Enrollment occurs at six medical centers in Taiwan and medication is to be started within two days of randomization. The trial compares lipid-lowering regimens (rosuvastatin or atorvastatin as the statin options) to see differences in cholesterol control and related clinical markers. Patients with statin or ezetimibe intolerance, end-stage renal disease, high ALT, or prior regular statin/ezetimibe use are excluded.

Who should consider this trial

Good fit: Adults (age ≥20) who had an ischemic stroke or TIA within the past 30 days, have atherosclerosis, and have LDL-C ≥100 mg/dL who have not been on regular statin or ezetimibe therapy are ideal candidates.

Not a fit: Patients with end-stage renal disease, prior intolerance to statins or ezetimibe, ALT >100 U/L, or who were taking statins or ezetimibe before the stroke are unlikely to benefit or are ineligible.

Why it matters

Potential benefit: If successful, adding ezetimibe could lower LDL-C more rapidly and may reduce the risk of recurrent vascular events after stroke.

How similar studies have performed: Previous trials adding ezetimibe to statins have reduced cardiovascular events after acute coronary syndromes, but early use specifically after ischemic stroke is less well studied.

Eligibility criteria

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.

Where this trial is running

Pozi

• Chang Gung Memorial Hospital, Chiayi Branch — Pozi, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Meng Lee, MD

Conditions: Ischemic Stroke, Hypercholesteremia, ischemic stroke, hypercholesteremia, statin, ezetimibe