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

NCT07307989 | Recruiting Phase 2

• 1 other identifier: NSTC 114-2314-B-182-019-
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesteremia; Ischemic Stroke

Keywords

ischemic stroke; hypercholesteremia; statin; ezetimibe

Outcome Measures

Primary Outcomes (1)

• LDL-C levels < 70 mg/dL

  6 months after randomization

Secondary Outcomes (1)

• LDL-C levels < 70 mg/dL

  3 months

Study Arms (2)

Statin plus ezetimibe

EXPERIMENTAL

Moderate-intensity statin plus ezetimibe as the interventional group. Both fixed-dose combination of statin/ezetimibe, such as Vytorin (simvastatin 20mg/ezetimibe 10mg), Atozet (atorvastatin 20mg/ezetimibe 10mg), Cretrol (rosuvastatin 10mg/ezetimibe 10mg) and one pill of ezetimibe added to moderate-intensity statins are allowed.

Drug: statin + ezetimibe

Statin monotherapy

ACTIVE COMPARATOR

Moderate- or high-intensity statin monotherapy, including atorvastatin 10-80 mg/d, rosuvastatin 5-20 mg/d, pitavastatin 1-4 mg/d

Drug: Statin monotherapy (rosuvastatin or atorvastatin)

Interventions

statin + ezetimibe DRUG

Moderate-intensity statin plus ezetimibe 10mg

Statin plus ezetimibe

Statin monotherapy (rosuvastatin or atorvastatin) DRUG

Moderate- or high-intensity statin monotherapy

Statin monotherapy

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Chang Gung University: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Chiayi Branch

Pozi, 613, Taiwan

RECRUITING

Related Publications (1)

• Lee M, Cheng CY, Wu YL, Lee JD, Hsu CY, Ovbiagele B. Association Between Intensity of Low-Density Lipoprotein Cholesterol Reduction With Statin-Based Therapies and Secondary Stroke Prevention: A Meta-analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Apr 1;79(4):349-358. doi: 10.1001/jamaneurol.2021.5578.

  PMID: 35188949 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Hypercholesterolemia

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ezetimibe; Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Meng Lee, MD

CONTACT

886978233755; menglee5126@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)