Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

Sponsor
Instituto Nacional de Cirugia Cardiaca, Uruguay (Other)
Overall Status
Completed
CT.gov ID
NCT03807921
Collaborator
Universidad de la Republica (Other)
140
2
2
12
70
5.9

Study Details

Study Description

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 Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Warfarin

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.

Drug: Warfarin
Oral anticoagulation
Other Names:
  • Choice
  • Drug: Aspirin
    Antiplatelet treatment
    Other Names:
  • AAS
  • Active Comparator: Aspirin only

    Aspirin will be started 48-72h after aortic valve replacement. Dose will be 100 mg daily. Patients who undergo coronary artery revascularization will receive 325 mg daily.

    Drug: Aspirin
    Antiplatelet treatment
    Other Names:
  • AAS
  • Outcome Measures

    Primary Outcome Measures

    1. Transprosthetic aortic gradient [3 months and 1 year]

      Change in Transprosthetic mean gradient

    2. Change in New York Heart Association (NYHA) class [1 year]

      NYHA class

    Secondary Outcome Measures

    1. Major bleeding [3 months and 1 year]

      number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion

    2. Embolic events [3 months and 1 year]

      Number of patients with cerebral and peripheral ischemic events

    3. Prosthetic leak [3 months and 1 year]

      Change in severity of prosthetic and paraprosthetic leakage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro Cardiovascular Universitario Montevideo Uruguay
    2 Instituto Nacional de Cirugia Cardiaca Montevideo Uruguay

    Sponsors and Collaborators

    • Instituto Nacional de Cirugia Cardiaca, Uruguay
    • Universidad de la Republica

    Investigators

    • Principal Investigator: Victor Dayan, MD, PhD, Instituto Nacional de Cirugia Cardiaca
    • Principal Investigator: Diego Freire, MD, Centro Cardiovascular Universitario

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Victor Dayan, Cardiac Surgeon, Instituto Nacional de Cirugia Cardiaca, Uruguay
    ClinicalTrials.gov Identifier:
    NCT03807921
    Other Study ID Numbers:
    • ANTIPRO
    First Posted:
    Jan 17, 2019
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Victor Dayan, Cardiac Surgeon, Instituto Nacional de Cirugia Cardiaca, Uruguay
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022