NCT02402491

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

Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The ISR-DAPT Study is a multicenter, randomized controlled trial that will enroll 1000 subjects treated with percutaneous coronary intervention (PCI) for in-stent restenosis. 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 after index procedure. 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 at 24 months.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	12 months of P2Y12 receptor antagonist	All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
DRUG	24 months of P2Y12 receptor antagonist	All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
DRUG	Aspirin	The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-03-30
• Last updated: 2015-03-30

Locations

1 site across 1 country: China