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

Phase 4

• Conditions: Percutaneous Coronary Intervention
• Interventions: Drug: 12 months of P2Y12 receptor antagonist; Drug: 24 months of P2Y12 receptor antagonist; Drug: Aspirin

• Registration Number: NCT02402491
• Lead Sponsor: Beijing Anzhen Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Study First Posted: 2015-03-30
• Last Update Posted: 2015-03-30
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 months of P2Y12 receptor antagonist	Aspirin	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.
12 months of P2Y12 receptor antagonist	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.
12 months of P2Y12 receptor antagonist	Aspirin	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.
24 months of P2Y12 receptor antagonist	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.

Primary Outcome Measures

Name	Time	Method
MACCE	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Safety end point assessed by incidence of GUSTO moderate or severe bleeding.	24 months	Specifically, bleeding complications are classified as severe if they are intracerebral or if they result in substantial hemodynamic compromise requiring treatment. Moderate bleeding is defined by the need for transfusion.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China