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Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.
The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term DAPT followed by clopidogrel monotherapy | Experimental | atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT. |
|
| Short-term DAPT followed by aspirin monotherapy | Active Comparator | Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel monotherapy | Drug | Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical events (NACE) | Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5) | 1 year after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Each component of NACE | 1 year after the procedure | |
| Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke) | 1 year after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
2. Left main bifurcation requiring 2-stent technique 3. Pregnant women or women with potential childbearing 4. Life expectancy < 1 year 5. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 6. Inability to understand or read the informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byeong-Keuk Kim | Contact | 82-2228-8460 | kimbk@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Byeong-Keuk Kim | Severance Cardiovascular Hospital, Yonsei University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
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| Aspirin monotherapy | Drug | Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT. |
|
| zotarolimus-eluting stent (Resolute Onyx ®) | Device | zotarolimus-eluting stent (Resolute Onyx ®) |
|
| Cardiac death | 1 year after the procedure |
| Stent thrombosis (definite or probable) | 1 year after the procedure |
| Target-vessel revascularization | 1 year after the procedure |
| Target-lesion revascularization | 1 year after the procedure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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