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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 100
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital, Chiayi Branch
RECRUITING
Pozi
Contact Information
Primary
Meng Lee, MD
menglee5126@gmail.com
886978233755
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 300
Treatments
Experimental: 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.
Active_comparator: Statin monotherapy
Moderate- or high-intensity statin monotherapy, including atorvastatin 10-80 mg/d, rosuvastatin 5-20 mg/d, pitavastatin 1-4 mg/d
Sponsors
Leads: Chang Gung Memorial Hospital
Collaborators: Chang Gung University

This content was sourced from clinicaltrials.gov