Percutaneous Coronary Intervention
Conditions
Keywords
Dual Antiplatelet Treatment, In-Stent Restenosis
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.
Interventions
DRUG12 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.
DRUG24 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.
DRUGAspirin
The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed