Status:
COMPLETED
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
Lead Sponsor:
Instituto Nacional de Cirugia Cardiaca, Uruguay
Collaborating Sponsors:
Universidad de la Republica
Conditions:
Aortic Valve Stenosis
Aortic Valve Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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....
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, mainl...
Eligibility Criteria
Inclusion
- Patients with indication of aortic valve replacement with porcine bioprosthesis
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03807921
Start Date
January 1 2019
End Date
December 31 2019
Last Update
March 8 2022
Active Locations (2)
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1
Centro Cardiovascular Universitario
Montevideo, Uruguay
2
Instituto Nacional de Cirugia Cardiaca
Montevideo, Uruguay