Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03807921

Enrollment

140

Registered

2019-01-17

Start date

2019-01-01

Completion date

2019-12-31

Last updated

2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis

Keywords

aortic valve replacement, bioprosthesis, anticoagulation

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).

Interventions

DRUGWarfarin

Oral anticoagulation

DRUGAspirin

Antiplatelet treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Transprosthetic aortic gradient	3 months and 1 year	Change in Transprosthetic mean gradient
Change in New York Heart Association (NYHA) class	1 year	NYHA class

Secondary

Measure	Time frame	Description
Major bleeding	3 months and 1 year	number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion
Embolic events	3 months and 1 year	Number of patients with cerebral and peripheral ischemic events
Prosthetic leak	3 months and 1 year	Change in severity of prosthetic and paraprosthetic leakage

Countries

Uruguay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026