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This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral anticoagulation therapy group | Experimental | Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5 |
|
| Single antiplatelet therapy group | Active Comparator | Aspirin, 75-100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral anticoagulation therapy | Drug | Vitamin-K antagonists (warfarin) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5) | A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5) | 1 year |
| Rates of bioprosthetic valve thrombosis detected by 4D-CT | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis | A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis | 1 year |
| Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjian Wu, MD,PhD | Contact | +86 13701387189 | yongjianwu_nccd@163.com | |
| Yunqing Ye, Master | Contact | +86 13699282532 | judia8510@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongjian Wu, MD,PhD | Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Study Chair |
| Yunqing Ye, Master | Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37989381 | Derived | Hu X, Xu H, Wang C, Wang Y, Wang Y, Zhou D, Zhu Q, Xu K, Yang J, Zhang H, Jiang N, Zhang J, Fang Z, Fu G, Guo Y, Li Y, Wang M, Feng D, Niu G, Zhang E, Chen Y, Ye Y, Wu Y. Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial. BMJ Open. 2023 Nov 21;13(11):e076781. doi: 10.1136/bmjopen-2023-076781. |
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| Single antiplatelet therapy |
| Drug |
Aspirin |
|
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5) |
| 1 year |
| Cardiac death | Cardiac death | 1 year |
| Minor bleeding (BRAC 2) | Minor bleeding (BRAC 2) | 1 year |
| Bleeding (BRAC 1, 2, 3a-c, 5) | Bleeding (BRAC 1, 2, 3a-c, 5) | 1 year |
| All-cause mortality | All-cause mortality | 1 year |
| Myocardial infarction | Myocardial infarction | 1 year |
| Stroke | Stroke | 1 year |
| TIA | TIA | 1 year |
| Peripheral artery thrombosis | Peripheral artery thrombosis | 1 year |
| Intracardiac thrombosis | Intracardiac thrombosis | 1 year |
| Major bleeding (BARC 3a) | Major bleeding (BARC 3a) | 1 year |
| Disabling/life-threatening bleeding (BARC 3b,3c,5) | Disabling/life-threatening bleeding (BARC 3b,3c,5) | 1 year |