Brief Title
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
Official Title
Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Brief Summary
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
Detailed Description
Aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. Current guidelines support the use of aspirin (AAS) 100 mg as a class I indication. Current evidence, mainly derived from transaortic valve implantation (TAVI) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. Anticoagulation in this cases improve leaflet mobility and decrease in gradient. Evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. Nonetheless, current American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend (IIa) the use of warfarin for at least 3 months after aortic valve replacement. The aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. Comparison will be performed between the use of warfarin + aspirin vs aspirin alone. Duration of anticoagulation will be for 3 months and patients follow-up for 1 year. Clinical and echocardiographic evaluation will be performed in every patients. Some patients will undergo Positron Emission Tomography (PET-Scan).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Transprosthetic aortic gradient
Secondary Outcome
Major bleeding
Condition
Aortic Valve Stenosis
Intervention
Warfarin
Study Arms / Comparison Groups
Warfarin
Description: Warfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months. Aspirin will be administered 100 mg 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
152
Start Date
January 1, 2019
Completion Date
December 31, 2019
Primary Completion Date
December 30, 2019
Eligibility Criteria
Inclusion Criteria: - Patients with indication of aortic valve replacement with porcine bioprosthesis Exclusion Criteria: - Concomitant mitral valve replacement - Previous atrial fibrillation - Previous use oral anticoagulation - Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy) - Jehovah witness - Platelet count below 90,000. - Liver disease
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Victor Dayan, MD, PhD, ,
Location Countries
Uruguay
Location Countries
Uruguay
Administrative Informations
NCT ID
NCT03807921
Organization ID
ANTIPRO
Responsible Party
Principal Investigator
Study Sponsor
Instituto Nacional de Cirugia Cardiaca, Uruguay
Collaborators
Universidad de la Republica
Study Sponsor
Victor Dayan, MD, PhD, Principal Investigator, Instituto Nacional de Cirugia Cardiaca
Verification Date
August 2020