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

Brief Title

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

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

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).

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

an incidence of leaflet thrombosis

Secondary Outcome

 Death

Condition

Aortic Valve Stenosis

Intervention

NOAC

Study Arms / Comparison Groups

 NOAC

Description:  60 mg once daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 15, 2018

Completion Date

December 2021

Primary Completion Date

October 2021

Eligibility 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.

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Seung-jung Park, MD, ,

Location Countries

Hong Kong

Location Countries

Hong Kong

Administrative Informations

NCT ID

NCT03284827

Organization ID

AMCCV 2017-08

Responsible Party

Sponsor-Investigator

Study Sponsor

Duk-Woo Park, MD

Collaborators

 CardioVascular Research Foundation, Korea

Study Sponsor

Seung-jung Park, MD, Principal Investigator, Cardiology, Asan Medical Center Heart Institute

Verification Date

April 2021