Aortic Valve Stenosis Clinical Trial
Official title:
Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Verified date | February 2022 |
Source | Instituto Nacional de Cirugia Cardiaca, Uruguay |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Uruguay | Centro Cardiovascular Universitario | Montevideo | |
Uruguay | Instituto Nacional de Cirugia Cardiaca | Montevideo |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cirugia Cardiaca, Uruguay | Universidad de la Republica |
Uruguay,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transprosthetic aortic gradient | Change in Transprosthetic mean gradient | 3 months and 1 year | |
Primary | Change in New York Heart Association (NYHA) class | NYHA class | 1 year | |
Secondary | Major bleeding | number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion | 3 months and 1 year | |
Secondary | Embolic events | Number of patients with cerebral and peripheral ischemic events | 3 months and 1 year | |
Secondary | Prosthetic leak | Change in severity of prosthetic and paraprosthetic leakage | 3 months and 1 year |
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