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

Chang Gung Medical Foundation

Status and phase: Enrolling; Phase 2

Conditions: Ischemic Stroke; Hypercholesteremia

Treatments: Drug: statin + ezetimibe; Drug: Statin monotherapy (rosuvastatin or atorvastatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT07307989

NSTC 114-2314-B-182-019-

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Statin plus ezetimibe

Experimental group

Description:

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.

Treatment:

Drug: statin + ezetimibe

Statin monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Statin monotherapy (rosuvastatin or atorvastatin)