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To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).
Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Aspirin | Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation. |
| |
| Experimental: Thienopyridine | Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). | 3-month | |
| Major adverse cardiac event | 3-month |
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Inclusion Criteria:
Exclusion Criteria:
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The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ken Kozuma, MD, PhD | Contact | +81-3-3964-1211 | PXE00364@nifty.com |
| Name | Affiliation | Role |
|---|---|---|
| Ken Kozuma, MD, PhD | Teikyo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teikyo University Hospital | Recruiting | Tokyo | 173-8606 | Japan |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C446540 | thienopyridine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Thienopyridine | Drug | Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion. |
|
| Major adverse cardiac event | 12-month |
| All cause death | 3-month |
| All cause death | 12-month |
| Cardiac death | 3-month |
| Cardiac death | 12-month |
| Myocardial infarction | 3-month |
| Myocardial infarction | 12-month |
| Stroke (ischemic and hemorrhagic) | 3-month |
| Stroke (ischemic and hemorrhagic) | 12-month |
| Target lesion revascularization | 3-month |
| Target lesion revascularization | 12-month |
| Target vessel revascularization | 3-month |
| Target vessel revascularization | 12-month |
| Readmission related to angina | 3-month |
| Readmission related to angina | 12-month |
| Stent thrombosis | 3-month |
| Stent thrombosis (ARC definition) | 12-month |
| Bleeding complications (BARC definition) | 3-month |
| Bleeding complications (BARC definition) | 12-month |
| Comparison of event rate by the type of antiplatelet agent | 12-month |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |