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

• ClinicalTrials.gov Identifier: NCT02402491
• Recruitment Status: Unknown
• First Posted: March 30, 2015
• Last Update Posted: March 30, 2015
• Sponsor: Beijing Anzhen Hospital
• Information provided by (Responsible Party): Yujie Zhou, Beijing Anzhen Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Percutaneous Coronary Intervention	Drug: 12 months of P2Y12 receptor antagonist; Drug: 24 months of P2Y12 receptor antagonist; Drug: Aspirin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis
• Study Start Date: January 2013
• Estimated Primary Completion Date: June 2015
• Estimated Study Completion Date: June 2015

Arms and Interventions

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: 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.; Drug: Aspirin; The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

Outcome Measures

Primary Outcome Measures :

1. MACCE [ Time Frame: 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 :

1. Safety end point assessed by incidence of GUSTO moderate or severe bleeding. [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

China, Beijing

Beijing Anzhen Hospital

Beijing, Beijing, China, 100029

Sponsors and Collaborators

Beijing Anzhen Hospital

Investigators

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

More Information

• Responsible Party: Yujie Zhou, professor of cardiology, vice president of Beijing Anzhen Hospital, Beijing Anzhen Hospital
• ClinicalTrials.gov Identifier: NCT02402491 History of Changes
• Other Study ID Numbers: ISR-DAPT
• First Posted: March 30, 2015
• Last Update Posted: March 30, 2015
• Last Verified: March 2015

Keywords provided by Yujie Zhou, Beijing Anzhen Hospital:

Dual Antiplatelet Treatment; In-Stent Restenosis

Additional relevant MeSH terms:

Aspirin; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents