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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Percutaneous Coronary Intervention

Treatments: Drug: Aspirin; Drug: 24 months of P2Y12 receptor antagonist; Drug: 12 months of P2Y12 receptor antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT02402491

ISR-DAPT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects 18-80 years of age
• Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis

Exclusion criteria

• Pregnant women
• Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
• Current medical condition with a life expectancy of <2 years
• Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
• Subjects on warfarin or similar anticoagulant therapy
• Subjects with hypersensitivity or allergies to one of the drugs
• Subjects unable to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups, including a placebo group

24 months of P2Y12 receptor antagonist

Active Comparator group

Description:

Receive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.

Treatment:

Drug: Aspirin

Drug: 24 months of P2Y12 receptor antagonist

12 months of P2Y12 receptor antagonist

Placebo Comparator group

Description:

Receive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure. All subjects receive aspirin for the duration of study.

Treatment:

Drug: 12 months of P2Y12 receptor antagonist

Drug: Aspirin