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

• Sponsor: Beijing Anzhen Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02402491
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Duration (Months): 28.9
• Patients Per Site Per Month: 34.5

Study Details

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
• Anticipated 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: Jan 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2015
• Anticipated Study Completion Date: Jun 1, 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 [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. [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

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

• Beijing Anzhen Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yujie Zhou, professor of cardiology, vice president of Beijing Anzhen Hospital, Beijing Anzhen Hospital
• ClinicalTrials.gov Identifier: NCT02402491
• Other Study ID Numbers: ISR-DAPT
• First Posted: Mar 30, 2015
• Last Update Posted: Mar 30, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Yujie Zhou, professor of cardiology, vice president of Beijing Anzhen Hospital, Beijing Anzhen Hospital: Dual Antiplatelet Treatment; In-Stent Restenosis
• Additional relevant MeSH terms: Aspirin; Purinergic P2Y Receptor Antagonists

Study Results

No Results Posted as of Mar 30, 2015