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We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.
Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel mono-therapy | Active Comparator | After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months. |
|
| Dual-antiplatelet therapy | Active Comparator | Patients will receive dual antiplatelet consisting of aspirin and clopidogrel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel mono-therapy | Drug | Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events (NACE) | The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Each component of net adverse clinical events | 24 months | |
| All-cause or cardiovascular mortality | 24 months | |
| Major or minor bleeding |
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Inclusion criteria (must all met)
High risk patients; clinical criteria
High risk lesions; angiographic or procedural criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea | Seoul | South Korea |
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Patients will be assigned to continue DAPT (aspirin plus clopidogrel) or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone) for further 24 months.
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Antiplatelet drugs will be open-label and prescribed by attending physician.
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| Dual-antiplatelet therapy | Drug | Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization. |
|
Major or minor bleeding would be defined by BARC and TIMI criteria |
| 24 months |
| Major adverse cardiac event | Major Adverse Cardiac events includes all-cause of death, myocardial infarction, stent thrombosis, or ischemia-driven target vessel revascularization | 24 months |
| Major adverse cardiac and cerebrovascular event | Major adverse cardiac and cerebrovascular event includes all-cause death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target vessel revascularization | 24 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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