A Phase 4 interventional study of Warfarin and Aspirin in Aortic Valve Stenosis, Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by Instituto Nacional de Cirugia Cardiaca, Uruguay. Completed at 2 sites in Uruguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Instituto Nacional de Cirugia Cardiaca, Uruguay · Phase 4, Interventional, and Treatment
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.
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).
Exclusion Criteria:
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 · Drug: Aspirin
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
Oral anticoagulation
Also known as: Choice
Antiplatelet treatment
Also known as: AAS
Transprosthetic aortic gradient
Change in Transprosthetic mean gradient
Time frame: 3 months and 1 year
Change in New York Heart Association (NYHA) class
NYHA class
Time frame: 1 year
Major bleeding
number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion
Time frame: 3 months and 1 year
Embolic events
Number of patients with cerebral and peripheral ischemic events
Time frame: 3 months and 1 year
Prosthetic leak
Change in severity of prosthetic and paraprosthetic leakage
Time frame: 3 months and 1 year
Plan to share: Yes — Study protocol.
Supporting information: Study protocol, Icf
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cirugia Cardiaca, Uruguay