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NOT YET RECRUITING
NCT07644234
PHASE4

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

Sponsor: Sichuan Provincial People's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3836

Start Date

2026-06

Completion Date

2029-10

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

Clopidogrel

Clopidogrel will be administered according to the assigned antiplatelet strategy. Participants receive a loading dose during screening and then clopidogrel 75 mg orally once daily during the assigned treatment period.

DRUG

Aspirin

Aspirin will be administered according to the assigned antiplatelet strategy. Participants receive aspirin during screening and then aspirin 100 mg orally once daily during the assigned treatment period.

Locations (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China