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This trial is a multinational, multicenter, randomized, open-label, active-controlled clinical trial comparing the safety of aspirin versus vitamin K antagonists (warfarin) as oral antithrombotic therapy during the initial 6 months following tissue valve replacement (aortic or mitral).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Antiplatelet Agent |
|
| warfarin | Active Comparator | Vitamin K antagonist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 100mg 1 tablet once daily for 6 months |
| |
| Vitamin K antagonist(warfarin) |
| Measure | Description | Time Frame |
|---|---|---|
| A composite endpoint is defined as a single outcome that combines multiple clinical events; the occurrence of any one of the component events is considered as meeting the endpoint. | From registration to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause mortality within 6 months | From registration to 6 months | |
| Number of participants who experienced stroke within 6 months | From registration to 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joon-bum Kim, MD | Contact | 82230105416 | jbkim1975@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Joon-Bum KIM, MD | jbkim1975@amc.seoul.kr | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cerebral and Cardiovascular Center Hospital | Not yet recruiting | Osaka | 564-8565 | Japan |
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| Drug |
Maintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months |
|
| Number of participants who experienced transient ischemic attack within 6 months |
| From registration to 6 months |
| Number of participants who experienced systemic embolism within 6 months | From registration to 6 months |
| Number of participants who experienced myocardial infarction within 6 months | From registration to 6 months |
| Number of participants who experienced major bleeding within 6 months | From registration to 6 months |
| Number of participants with valve thrombosis at 6 months | From registration to 6 months |
| Osaka University Hospital | Not yet recruiting | Osaka | 565-0871 | Japan |
|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
|
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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