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Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement (ADAPT-TAVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284827
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Daiichi Sankyo Korea Co., Ltd.
Information provided by (Responsible Party):
Duk-Woo Park, MD, Asan Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: NOAC Drug: DAPT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: a Multicenter, Randomized, Open-label, Active-treatment, Controlled Trial to Compare the Efficacy of NOAC With Edoxaban vs. Dual Antiplatelet Therapy (DAPT) for Prevention of Leaflet Thrombosis (Documented by Cardiac CT Imaging) and Cerebral Embolization (Documented With Brain DW-MRI Imaging) in Patients Without an Absolute Indication for Chronic OAC After Successful TAVR
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: NOAC
60 mg once daily
Drug: NOAC
edoxaban (60 mg once daily [OD]) for at least 6 months

Active Comparator: DAPT
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
Drug: DAPT
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months




Primary Outcome Measures :
  1. an incidence of leaflet thrombosis [ Time Frame: 6-month ]
    an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging


Secondary Outcome Measures :
  1. Death [ Time Frame: 6-month ]
    all-cause, cardiovascular, or non-cardiovascular mortality

  2. Myocardial infarction [ Time Frame: 6-month ]
  3. Stroke or transient ischemic attack [ Time Frame: 6-month ]
    disabling or non-disabling

  4. Bleeding event [ Time Frame: 6-month ]
    life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition

  5. The change of Echocardiographic parameter [ Time Frame: 6-month ]
    the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up

  6. New lesion volume on MRI scans [ Time Frame: 6-month ]
  7. The change of neurological and neurocognitive function [ Time Frame: 6-month ]
    according to NeuroARC(Neuro Academic Research Consortium) definition

  8. the number of new lesions on brain DW-MRI scans [ Time Frame: 6-month ]
    the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

      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:

  1. Any atrial fibrillation with an indication for chronic OAC.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284827


Contacts
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Contact: Duk-woo Park, MD 82230103995 dwpark@amc.seoul.kr

Locations
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Hong Kong
Queen Mary Hospital Recruiting
High West, Hong Kong
Contact: LAM Cheung Chi Lam, MD       drsimonlam@gmail.com   
Principal Investigator: LAM Cheung Chi Lam, MD         
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Duk-woo Park, MD       dwpark@amc.seoul.kr   
Principal Investigator: Duk-woo Park, MD         
Bundang CHA Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Won-jang Kim, MD       mdwjkim@gmail.com   
Principal Investigator: Won-jang Kim, MD         
Taiwan
Cheng Hsin General Hospital Recruiting
Taipei, Taiwan
Contact: Jeng Wei, MD       chghjw@yahoo.com.tw   
Principal Investigator: Jeng Wei, MD         
Sponsors and Collaborators
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea
Daiichi Sankyo Korea Co., Ltd.
Investigators
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Principal Investigator: Seung-jung Park, MD Cardiology, Asan Medical Center Heart Institute
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Responsible Party: Duk-Woo Park, MD, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03284827    
Other Study ID Numbers: AMCCV 2017-08
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duk-Woo Park, MD, Asan Medical Center:
edoxaban
dual antiplatelet therapy
cerebral embolization
leaflet thrombosis
Additional relevant MeSH terms:
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Thrombosis
Aortic Valve Stenosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction