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

NCT ID: NCT02402491

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

24 months of P2Y12 receptor antagonist

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.

Group Type: ACTIVE_COMPARATOR

24 months of P2Y12 receptor antagonist

Intervention Type: DRUG

All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.

Aspirin

Intervention Type: DRUG

The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

12 months of P2Y12 receptor antagonist

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.

Group Type: PLACEBO_COMPARATOR

12 months of P2Y12 receptor antagonist

Intervention Type: DRUG

All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.

Aspirin

Intervention Type: DRUG

The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Aspirin

The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yujie Zhou

professor of cardiology, vice president of Beijing Anzhen Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yujie Zhou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ISR-DAPT

Identifier Type: -

Identifier Source: org_study_id