The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial

What this Trial Is About

Researchers are evaluating the effects and safety of adding cilostazol to standard treatment with aspirin and clopidogrel in adults who have had an acute ischemic stroke caused by large artery atherosclerosis. This condition involves narrowing of arteries supplying the brain, which can lead to stroke. The study focuses on whether cilostazol can help reduce early stroke recurrence and neurological deterioration, especially for patients with large artery atherosclerosis, based on prior trial data suggesting potential benefits. Participants will be randomly assigned to one of two groups. One group will receive aspirin 100 mg daily for 21 days, clopidogrel 75 mg daily for 180 days, and cilostazol sustained release 100 mg twice daily for 180 days. The other group will receive aspirin 100 mg daily for 21 days, clopidogrel 75 mg daily for 180 days, and a placebo twice daily for 180 days. If a participant undergoes stenting, aspirin will be added to cilostazol or placebo and clopidogrel until 90 days after the procedure. During the study, researchers will monitor participants for stroke recurrence, neurological deterioration, functional outcomes assessed by the modified Rankin Scale at 90 and 180 days, and other cardiovascular events such as myocardial infarction and vascular death. The primary outcome is the occurrence of a composite endpoint during hospital admission (within 14 days) and up to 180 days after stroke. The study includes triple masking and will last until March 2028, with all study visits and assessments conducted as scheduled to evaluate treatment effects and safety.

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