Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
| Daiichi Sankyo Korea Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic resonance (MR) imaging) in patients without an absolute indication for chronic oral anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOAC | Experimental | 60 mg once daily |
|
| DAPT | Active Comparator | clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOAC | Drug | edoxaban (60 mg once daily [OD]) for at least 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| an incidence of leaflet thrombosis | an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Death | all-cause, cardiovascular, or non-cardiovascular mortality | 6-month |
| Myocardial infarction | 6-month | |
Not provided
Inclusion Criteria:
Patients 19 years of age or older with successful TAVR procedure
either native valve or valve-in-valve with any approved/marketed device
A successful TAVR is defined as device success according to the VARC-2 criteria:
Patients who voluntarily participated in the written agreement
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seung-jung Park, MD | Cardiology, Asan Medical Center Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong | ||||
| Asan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38151311 | Derived | Choi Y, Ahn JM, Kang DY, Kim HJ, Kim H, Lee J, Kim M, Park J, Kim KW, Koo HJ, Yang DH, Jung SC, Kim B, Anthony Wong YT, Simon Lam CC, Yin WH, Wei J, Lee YT, Kao HL, Lin MS, Ko TY, Kim WJ, Kang SH, Lee SA, Kim DH, Lee JH, Park SJ, Park DW; ADAPT-TAVR Investigators. Frequency, Predictors, and Clinical Impact of Valvular and Perivalvular Thrombus After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2967-2981. doi: 10.1016/j.jcin.2023.10.024. | |
| 37586823 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DAPT |
| Drug |
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months |
|
| Stroke or transient ischemic attack |
disabling or non-disabling |
| 6-month |
| Bleeding event | life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition | 6-month |
| The change of Echocardiographic parameter | the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up | 6-month |
| New lesion volume on MRI scans | 6-month |
| The change of neurological and neurocognitive function | according to NeuroARC(Neuro Academic Research Consortium) definition | 6-month |
| the number of new lesions on brain DW-MRI scans | the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR | 6-month |
| Seoul |
| Songpa-gu |
| 138-736 |
| South Korea |
| Bundang CHA Hospital | Seongnam | South Korea |
| Cheng Hsin General Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Derived |
| Jang MH, Ahn JM, Kang DY, Kim KW, Koo HJ, Yang DH, Jung SC, Kim B, Wong YTA, Lam CCS, Yin WH, Wei J, Lee YT, Kao HL, Lin MS, Ko TY, Kim WJ, Kang SH, Ko E, Lee SA, Kim DH, Kim H, Choi Y, Lee J, Park SJ, Park DW. Impact of leaflet thrombosis on valve haemodynamic status after transcatheter aortic valve replacement. Heart. 2023 Dec 20;110(2):140-147. doi: 10.1136/heartjnl-2023-322946. |
| 35373583 | Derived | Park DW, Ahn JM, Kang DY, Kim KW, Koo HJ, Yang DH, Jung SC, Kim B, Wong YTA, Lam CCS, Yin WH, Wei J, Lee YT, Kao HL, Lin MS, Ko TY, Kim WJ, Kang SH, Yun SC, Lee SA, Ko E, Park H, Kim DH, Kang JW, Lee JH, Park SJ; ADAPT-TAVR Investigators. Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial. Circulation. 2022 Aug 9;146(6):466-479. doi: 10.1161/CIRCULATIONAHA.122.059512. Epub 2022 Apr 4. |
| 33402409 | Derived | Park H, Kang DY, Ahn JM, Kim KW, Wong AYT, Lam SCC, Yin WH, Wei J, Lee YT, Kao HL, Lin MS, Ko TY, Kim WJ, Kang SH, Ko E, Kim DH, Koo HJ, Yang DH, Kang JW, Jung SC, Lee JH, Yun SC, Park SJ, Park DW. Rationale and design of the ADAPT-TAVR trial: a randomised comparison of edoxaban and dual antiplatelet therapy for prevention of leaflet thrombosis and cerebral embolisation after transcatheter aortic valve replacement. BMJ Open. 2021 Jan 5;11(1):e042587. doi: 10.1136/bmjopen-2020-042587. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| ID | Term |
|---|---|
| C065145 | N(4)-oleylcytosine arabinoside |
Not provided
Not provided
Not provided