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Completed

NCT Number: NCT03807921

Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Cardiovascular Universitario, Montevideo, Uruguay

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

Oral anticoagulation

Other names: Choice

Aspirin

Drug

Antiplatelet treatment

Other names: AAS

Primary outcomes

  1. Transprosthetic aortic gradient

    Time frame: 3 months and 1 year

    Change in Transprosthetic mean gradient

  2. Change in New York Heart Association (NYHA) class

    Time frame: 1 year

    NYHA class

Secondary outcomes

  1. Major bleeding

    Time frame: 3 months and 1 year

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

  2. Embolic events

    Time frame: 3 months and 1 year

    Number of patients with cerebral and peripheral ischemic events

  3. Prosthetic leak

    Time frame: 3 months and 1 year

    Change in severity of prosthetic and paraprosthetic leakage

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cirugia Cardiaca, Uruguay

Other

Collaborators

  • Universidad de la Republica

Registry information

Official study title

Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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