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

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.

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: 24 months of P2Y12 receptor antagonist; Drug: Aspirin; Drug: 12 months of P2Y12 receptor antagonist

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Placebo Comparator: 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.	Drug: Aspirin; The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Yujie Zhou, MD, PhD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Dual Antiplatelet Treatment; In-Stent Restenosis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Purinergic P2Y Receptor Antagonists
• Other Study ID Numbers: ISR-DAPT