Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
Primary Purpose
Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency
Status
Completed
Phase
Phase 4
Locations
Uruguay
Study Type
Interventional
Intervention
Warfarin
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring aortic valve replacement, bioprosthesis, anticoagulation
Eligibility Criteria
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
Sites / Locations
- Centro Cardiovascular Universitario
- Instituto Nacional de Cirugia Cardiaca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Warfarin
Aspirin only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Transprosthetic aortic gradient
Change in Transprosthetic mean gradient
Change in New York Heart Association (NYHA) class
NYHA class
Secondary Outcome Measures
Major bleeding
number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion
Embolic events
Number of patients with cerebral and peripheral ischemic events
Prosthetic leak
Change in severity of prosthetic and paraprosthetic leakage
Full Information
NCT ID
NCT03807921
First Posted
January 15, 2019
Last Updated
February 21, 2022
Sponsor
Instituto Nacional de Cirugia Cardiaca, Uruguay
Collaborators
Universidad de la Republica
1. Study Identification
Unique Protocol Identification Number
NCT03807921
Brief Title
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
Official Title
Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cirugia Cardiaca, Uruguay
Collaborators
Universidad de la Republica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Regurgitation
Keywords
aortic valve replacement, bioprosthesis, anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Warfarin
Arm Type
Experimental
Arm Description
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.
Arm Title
Aspirin only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Choice
Intervention Description
Oral anticoagulation
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
AAS
Intervention Description
Antiplatelet treatment
Primary Outcome Measure Information:
Title
Transprosthetic aortic gradient
Description
Change in Transprosthetic mean gradient
Time Frame
3 months and 1 year
Title
Change in New York Heart Association (NYHA) class
Description
NYHA class
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Major bleeding
Description
number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion
Time Frame
3 months and 1 year
Title
Embolic events
Description
Number of patients with cerebral and peripheral ischemic events
Time Frame
3 months and 1 year
Title
Prosthetic leak
Description
Change in severity of prosthetic and paraprosthetic leakage
Time Frame
3 months and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Dayan, MD, PhD
Organizational Affiliation
Instituto Nacional de Cirugia Cardiaca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diego Freire, MD
Organizational Affiliation
Centro Cardiovascular Universitario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Cardiovascular Universitario
City
Montevideo
Country
Uruguay
Facility Name
Instituto Nacional de Cirugia Cardiaca
City
Montevideo
Country
Uruguay
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol.
IPD Sharing Time Frame
From January 2019
IPD Sharing Access Criteria
Protocol will be shared by email. Investigators interested should send email to the PI who will evaluate the solicitude.
Citations:
PubMed Identifier
36308446
Citation
Fernandez A, Loza G, Parma G, Florio L, Estigarribia J, Soca G, Robaina R, Duran A, Brusich D, Dayan V. Early anticoagulation after aortic valve replacement with porcine bioprosthesis randomized control trial (ANTIPRO). Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezac507. doi: 10.1093/ejcts/ezac507.
Results Reference
derived
Learn more about this trial
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
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