drugset / Trial / NCT02869009

Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke

NCT02869009 ↗

Phase 3 Completed 3000 enrolled General Hospital of Shenyang Military Region
RandomizedParallel-groupOpen-labelTreatment

Summary

The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.

Timeline

Start
2016-11
Primary completion
2022-10-31
Completion
2022-10-31

Outcome

Met primary endpoint

paper Early neurologic deterioration occurred in 72 of 1502 (4.8%) in the dual antiplatelet therapy group vs 95 of 1413 (6.7%) in the aspirin alone group PMID 38466274 ↗

paper risk difference -1.9%; 95% CI, -3.6 to -0.2; P = .03 PMID 38466274 ↗

paper clopidogrel plus aspirin was superior to aspirin alone with regard to reducing early neurologic deterioration at 7 days PMID 38466274 ↗

Publications

Drugs

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

Indications