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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: 12 months of P2Y12 receptor antagonist
* Drug: 24 months of P2Y12 receptor antagonist
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24 months of P2Y12 receptor antagonist<br>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. | Drug: 24 months of P2Y12 receptor antagonist<br>* All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.<br>Drug: Aspirin<br>* The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.<br>|
| Placebo Comparator: 12 months of P2Y12 receptor antagonist<br>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. | Drug: 12 months of P2Y12 receptor antagonist<br>* All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.<br>Drug: Aspirin<br>* The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety end point assessed by incidence of GUSTO moderate or severe bleeding. | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual Antiplatelet Treatment, In-Stent Restenosis