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

NCT ID: NCT07307989

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2029-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke Hypercholesteremia

Keywords

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ischemic stroke hypercholesteremia statin ezetimibe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Statin plus ezetimibe

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.

Group Type EXPERIMENTAL

statin + ezetimibe

Intervention Type DRUG

Moderate-intensity statin plus ezetimibe 10mg

Statin monotherapy

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

Group Type ACTIVE_COMPARATOR

Statin monotherapy (rosuvastatin or atorvastatin)

Intervention Type DRUG

Moderate- or high-intensity statin monotherapy

Interventions

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statin + ezetimibe

Moderate-intensity statin plus ezetimibe 10mg

Intervention Type DRUG

Statin monotherapy (rosuvastatin or atorvastatin)

Moderate- or high-intensity statin monotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung University

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital, Chiayi Branch

Pozi, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Meng Lee, MD

Role: CONTACT

Phone: 886978233755

Email: [email protected]

Facility Contacts

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Meng Lee, MD

Role: primary

References

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Derynck R, Gelbart WM, Harland RM, Heldin CH, Kern SE, Massague J, Melton DA, Mlodzik M, Padgett RW, Roberts AB, Smith J, Thomsen GH, Vogelstein B, Wang XF. Nomenclature: vertebrate mediators of TGFbeta family signals. Cell. 1996 Oct 18;87(2):173. doi: 10.1016/s0092-8674(00)81335-5. No abstract available.

Reference Type RESULT
PMID: 8861901 (View on PubMed)

Other Identifiers

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NSTC 114-2314-B-182-019-

Identifier Type: -

Identifier Source: org_study_id