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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807921
Other study ID # ANTIPRO
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2019

Study information

Verified date February 2022
Source Instituto Nacional de Cirugia Cardiaca, Uruguay
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Warfarin
Oral anticoagulation
Aspirin
Antiplatelet treatment

Locations

Country Name City State
Uruguay Centro Cardiovascular Universitario Montevideo
Uruguay Instituto Nacional de Cirugia Cardiaca Montevideo

Sponsors (2)

Lead Sponsor Collaborator
Instituto Nacional de Cirugia Cardiaca, Uruguay Universidad de la Republica

Country where clinical trial is conducted

Uruguay, 

Outcome

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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