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NCT Number: NCT07307989

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

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.

Recruiting

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyslipidemias Hypercholesteremia Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital, Chiayi Branch

Pozi, 613, Taiwan

Location status: Recruiting

Location contact

Meng Lee, MD

CONTACT

[email protected]

886978233755

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

statin + ezetimibe

Drug

Moderate-intensity statin plus ezetimibe 10mg

Statin monotherapy (rosuvastatin or atorvastatin)

Drug

Moderate- or high-intensity statin monotherapy

Primary outcomes

  1. LDL-C levels < 70 mg/dL

    Time frame: 6 months after randomization

Secondary outcomes

  1. LDL-C levels < 70 mg/dL

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Lee, MD

CONTACT

[email protected]

886978233755

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Chang Gung University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 29, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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