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
220
Start Date
March 15, 2018
Completion Date
June 2021
Primary Completion Date
December 2020
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, 82230103995, [email protected]
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
December 2019