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

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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

Tracking Information
First Submitted Date  ICMJE September 12, 2017
First Posted Date  ICMJE September 15, 2017
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE March 15, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
an incidence of leaflet thrombosis [ Time Frame: 6-month ]
an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • an incidence of leaflet thrombosis [ Time Frame: 6-month ]
    an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging
  • the number of new lesions on brain DW-MRI scans [ Time Frame: 6 months ]
    the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • Death [ Time Frame: 6-month ]
    all-cause, cardiovascular, or non-cardiovascular mortality
  • Myocardial infarction [ Time Frame: 6-month ]
  • Stroke or transient ischemic attack [ Time Frame: 6-month ]
    disabling or non-disabling
  • 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
  • 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
  • New lesion volume on MRI scans [ Time Frame: 6-month ]
  • The change of neurological and neurocognitive function [ Time Frame: 6-month ]
    according to NeuroARC(Neuro Academic Research Consortium) definition
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Death [ Time Frame: 6-month ]
    all-cause, cardiovascular, or non-cardiovascular mortality
  • Myocardial infarction [ Time Frame: 6-month ]
  • Stroke or transient ischemic attack [ Time Frame: 6-month ]
    disabling or non-disabling
  • 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
  • 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
  • New lesion volume on MRI scans [ Time Frame: 6-month ]
  • The change of neurological and neurocognitive function [ Time Frame: 6-month ]
    according to NeuroARC(Neuro Academic Research Consortium) definition
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE
  • Drug: NOAC
    edoxaban (60 mg once daily [OD]) for at least 6 months
  • Drug: DAPT
    clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months
Study Arms  ICMJE
  • Experimental: NOAC
    60 mg once daily
    Intervention: Drug: NOAC
  • Active Comparator: DAPT
    clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
    Intervention: Drug: DAPT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Duk-woo Park, MD 82230103995 dwpark@amc.seoul.kr
Listed Location Countries  ICMJE Hong Kong,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03284827
Other Study ID Numbers  ICMJE AMCCV 2017-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duk-Woo Park, MD, Asan Medical Center
Study Sponsor  ICMJE Duk-Woo Park, MD
Collaborators  ICMJE
  • CardioVascular Research Foundation, Korea
  • Daiichi Sankyo Korea Co., Ltd.
Investigators  ICMJE
Principal Investigator: Seung-jung Park, MD Cardiology, Asan Medical Center Heart Institute
PRS Account Asan Medical Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP