Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
NCT ID: NCT03284827
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
235 participants
INTERVENTIONAL
2018-03-15
2021-11-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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NOAC
60 mg once daily
NOAC
edoxaban (60 mg once daily \[OD\]) for at least 6 months
DAPT
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
DAPT
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months
Interventions
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NOAC
edoxaban (60 mg once daily \[OD\]) for at least 6 months
DAPT
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months
Eligibility Criteria
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Inclusion Criteria
* 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:
1. correct positioning of a single prosthetic heart valve into the proper anatomical location AND
2. Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch\* and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, no moderate or severe prosthetic valve regurgitation AND
3. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure.
2. Patients who voluntarily participated in the written agreement
Exclusion Criteria
2. An ongoing indication for OAC or any other indication for continued treatment with any OAC
3. Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12 months)
4. Planned coronary or vascular intervention or major surgery
5. Clinically significant bleeding patients
6. The risk of bleeding increased due to the following reasons at the time of TAVR procedure, i. history of gastrointestinal ulcers within 1 month ii. Malignant tumor with high risk of bleeding iii. Brain or spinal cord injury within 1 month iv. History of intracranial or intracerebral hemorrhage within 12 months v. Esophageal varices vi. Arteriovenous malformation vii. Vascular aneurysms viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities ix. Active bleeding x. Hemoglobin level \<7.0 g/dL or platelet count ≤ 50,000 / mm3 xi. History of major surgery within 1 month
7. Clinically overt stroke within the last 3 months
8. Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy
9. Severe renal impairment (CrCl by Cockcroft-Gault equation\<15 mL/min per 1.73 m2), chronic dialysis, or post-TAVR unresolved acute kidney injury
10. Terminal illness with life expectancy \<6 months
11. Hypersensitivity to the main component or constituents of Edoxaban
12. Severe hypertensive patient
13. Patient who received prosthetic heart valve replacement for which anticoagulant therapy is essential
14. Moderate to severe mitral stenosis
15. Pulmonary embolism requiring thrombolysis or pulmonary embolectomy
16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
17. Pregnancy test results are positive (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days prior to screening and / or randomization) or during pregnancy or lactation
18. Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
19. History of hypersensitivity to Edoxaban, Aspirin or clopidogrel
20. Current or history of Aspirin- or NSAIDs-induced asthma
21. Hemophilia
22. Patients who are using Methotrexate at doses of 15mg or more per week
23. Patients who have unsuitable condition to undergo Brain MRI(Magnetic resonance imaging) and/or Cardiac CT(computed tomography) (e.g., tremor from Parkinson's disease). This is at the discretion of investigators.
19 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Daiichi Sankyo Korea Co., Ltd.
INDUSTRY
Duk-Woo Park, MD
OTHER
Responsible Party
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Duk-Woo Park, MD
Professor
Principal Investigators
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Seung-jung Park, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiology, Asan Medical Center Heart Institute
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Asan Medical Center
Seoul, Songpa-gu, South Korea
Bundang CHA Hospital
Seongnam, , South Korea
Cheng Hsin General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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AMCCV 2017-08
Identifier Type: -
Identifier Source: org_study_id