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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 months of P2Y12 receptor antagonist | Active Comparator | 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. |
|
| 12 months of P2Y12 receptor antagonist | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 months of P2Y12 receptor antagonist | Drug | All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin. |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety end point assessed by incidence of GUSTO moderate or severe bleeding. | 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yujie Zhou, MD, PhD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
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| 24 months of P2Y12 receptor antagonist | Drug | All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin. |
|
| Aspirin | Drug | The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely. |
|
| ID | Term |
|---|---|
| D058921 | Purinergic P2Y Receptor Antagonists |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D058919 | Purinergic P2 Receptor Antagonists |
| D058914 | Purinergic Antagonists |
| D058905 | Purinergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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