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Aortic Valve StenosisPhase 4ADAPT-TAVRNCT03284827

Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement

A Phase 4 study testing NOAC and DAPT in people with Aortic Valve Stenosis, run by Duk-Woo Park, MD at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
NOAC and DAPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
5 sitesin 3 countries
Study dates
15 Mar 2018to 5 Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • correct positioning of a single prosthetic heart valve into the proper anatomical location AND
  • 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
  • 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.
  • Patients who voluntarily participated in the written agreement

Who cannot join

  • Any atrial fibrillation with an indication for chronic OAC.
  • An ongoing indication for OAC or any other indication for continued treatment with any OAC
  • Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12 months)
  • Planned coronary or vascular intervention or major surgery
  • Clinically significant bleeding patients
  • 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
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  • Clinically overt stroke within the last 3 months
  • Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy
  • Severe renal impairment (CrCl by Cockcroft-Gault equation<15 mL/min per 1.73 m2), chronic dialysis, or post-TAVR unresolved acute kidney injury
  • Terminal illness with life expectancy <6 months
  • Hypersensitivity to the main component or constituents of Edoxaban
  • Severe hypertensive patient
  • Patient who received prosthetic heart valve replacement for which anticoagulant therapy is essential
  • Moderate to severe mitral stenosis
  • Pulmonary embolism requiring thrombolysis or pulmonary embolectomy
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • 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
  • Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • History of hypersensitivity to Edoxaban, Aspirin or clopidogrel
  • Current or history of Aspirin- or NSAIDs-induced asthma
  • Hemophilia
  • Patients who are using Methotrexate at doses of 15mg or more per week
  • 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.

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

South Korea2 sites

  • Bundang CHA Hospital

    Seongnam

  • Asan Medical Center

    Seoul, Songpa-gu, 138-736

Other trials in South Korea

Taiwan2 sites

  • Cheng Hsin General Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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).

Being tested
NOAC, DAPT
Keywords
edoxaban, dual antiplatelet therapy, cerebral embolization, leaflet thrombosis
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOACDrug

    edoxaban (60 mg once daily [OD]) for at least 6 months

  • DAPTDrug

    clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months

Study groups in NCT03284827
Study groupRoleWhat they receive
NOACExperimental60 mg once daily
Receives: Drug: NOAC
DAPTActive comparatorclopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
Receives: Drug: DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. an incidence of leaflet thrombosis

    an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging

    Measured: 6-month

Secondary outcomes (8)

  1. Death

    all-cause, cardiovascular, or non-cardiovascular mortality

    Measured: 6-month

  2. Myocardial infarction

    Measured: 6-month

  3. Stroke or transient ischemic attack

    disabling or non-disabling

    Measured: 6-month

  4. Bleeding event

    life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition

    Measured: 6-month

  5. The change of Echocardiographic parameter

    the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up

    Measured: 6-month

  6. New lesion volume on MRI scans

    Measured: 6-month

  7. The change of neurological and neurocognitive function

    according to NeuroARC(Neuro Academic Research Consortium) definition

    Measured: 6-month

  8. 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

    Measured: 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2017
  2. Study start15 Mar 2018
  3. Primary completion26 Oct 2021
  4. Study completion5 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03284827
Sponsor's protocol ID
AMCCV 2017-08
Acronym
ADAPT-TAVR
Status last verified
Nov 2021
First submitted
12 Sep 2017
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Park HS, Suh CH, Ahn JM, Kang DY, Ahn SY, Wee SB, Lee SH, Seo KW, Kim MJ, Park SJ, Park DW. Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry. Am Heart J. 2026 Jan;291:44-52. doi: 10.1016/j.ahj.2025.08.006. Epub 2025 Aug 14.

    PubMed 40816554

  • 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.

    PubMed 38151311

  • 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.

    PubMed 37586823

  • 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.

    PubMed 35373583

  • 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.

    PubMed 33402409

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NOAC and DAPT in people with Aortic Valve Stenosis, run by Duk-Woo Park, MD at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

an incidence of leaflet thrombosis (time frame: 6-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03284827, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.

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