Clinical trial NCT02402491: Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis
Official title: Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Keywords: Dual Antiplatelet Treatment
In-Stent Restenosis
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: MACCE
timeFrame: 24 months
Secondary outcomes:
measure: Safety end point assessed by incidence of GUSTO moderate or severe bleeding.
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: