drugset / Trial / NCT07644234

Platelet Aggregation Function-Guided De-Escalation Antiplatelet Therapy in Patients With Acute Ischemic Stroke

NCT07644234

Phase 4 Not yet recruiting 3836 enrolled Sichuan Provincial People's Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or high-risk transient ischemic attack who are sensitive to clopidogrel. Participants who present within 48 hours of symptom onset and meet the eligibility criteria will receive loading doses of clopidogrel and aspirin, followed by platelet aggregation function testing. Eligible clopidogrel-sensitive participants will be randomized to receive either 7 days of dual antiplatelet therapy followed by clopidogrel monotherapy or standard 21-day dual antiplatelet therapy followed by single antiplatelet therapy. The primary efficacy outcome is new stroke within 90 days after randomization.

Timeline

Start
2026-06
Primary completion
2028-12
Completion
2029-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg Oral
Subject Clopidogrel Small molecule 75 mg Oral