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

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Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement Remote Ischemic Preconditioning for Renal Protection in TAVI Avr Thrombosis OutcoMe Study PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry Virtual Reality Assisted Conscious Sedation During TAVI The Aortic Valve DECalcification (AVADEC) Trial Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial) Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta. 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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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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