Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807921
• Other study ID #: ANTIPRO
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

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

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