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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07307989

Enrollment

300

Registered

2025-12-29

Start date

2025-08-01

Completion date

2029-07-31

Last updated

2025-12-30

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

Conditions

Hypercholesteremia, Ischemic Stroke

Keywords

ischemic stroke, hypercholesteremia, statin, ezetimibe

Brief 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.

Interventions

DRUGStatin monotherapy (rosuvastatin or atorvastatin)

Moderate- or high-intensity statin monotherapy

DRUGstatin + ezetimibe

Moderate-intensity statin plus ezetimibe 10mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

To test statin plus ezetimibe vs statin monotherapy to lower LDL-C \< 70 mg/dl

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
LDL-C levels < 70 mg/dL	6 months after randomization

Secondary

Measure	Time frame
LDL-C levels < 70 mg/dL	3 months

Countries

Taiwan

Contacts

Primary ContactMeng Lee, MD

menglee5126@gmail.com886978233755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026