Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Oral anticoagulation

Aspirin

Intervention Type DRUG

Antiplatelet treatment

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.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Antiplatelet treatment

Interventions

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Warfarin

Oral anticoagulation

Intervention Type DRUG

Aspirin

Antiplatelet treatment

Intervention Type DRUG

Other Intervention Names

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Choice AAS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No