drugset / Trial / NCT02402491

Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis

NCT02402491

Phase 4 Unknown 1000 enrolled Beijing Anzhen Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.

Timeline

Start
2013-01
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule
Comparator Prasugrel Small molecule
Comparator Ticagrelor Small molecule
Comparator Aspirin Small molecule 100 mg

Indications

No indication recorded.