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

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ClinicalTrials.gov Identifier: NCT02402491
Recruitment Status : Unknown
Verified March 2015 by Yujie Zhou, Beijing Anzhen Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Yujie Zhou, 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.

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402491


Locations
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China, Beijing
Beijing Anzhen Hospital
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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Principal Investigator: Yujie Zhou, MD, PhD Beijing Anzhen Hospital

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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    Key Record Dates
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:
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Aspirin
Purinergic P2Y 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 P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents