Early combined statin and ezetimibe treatment versus statin alone after ischemic stroke with atherosclerosis
Official title: 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
Run by Chang Gung Memorial Hospital · NCT07307989 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Pozi) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | July 31, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT07307989 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Chang Gung Memorial Hospital, Chiayi Branch
Pozi, Taiwan Recruiting
Study contacts
- Study coordinator: Meng Lee, MD
- Email: menglee5126@gmail.com
- Phone: 886978233755
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.