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Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

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ClinicalTrials.gov Identifier: NCT03807921
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Universidad de la Republica
Information provided by (Responsible Party):
Victor Dayan, Instituto Nacional de Cirugia Cardiaca, Uruguay

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Regurgitation Drug: Warfarin Drug: Aspirin Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: 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.

Drug: Warfarin
Oral anticoagulation
Other Name: Choice

Drug: Aspirin
Antiplatelet treatment
Other Name: AAS

Active Comparator: 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.
Drug: Aspirin
Antiplatelet treatment
Other Name: AAS




Primary Outcome Measures :
  1. Transprosthetic aortic gradient [ Time Frame: 3 months and 1 year ]
    Change in Transprosthetic maximum gradient

  2. Change in New York Heart Association (NYHA) class [ Time Frame: 1 year ]
    NYHA class


Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: 3 months and 1 year ]
    number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion

  2. Embolic events [ Time Frame: 3 months and 1 year ]
    Number of patients with cerebral and peripheral ischemic events

  3. Prosthetic leak [ Time Frame: 3 months and 1 year ]
    Change in severity of prosthetic and paraprosthetic leakage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with indication of aortic valve replacement with 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807921


Contacts
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Contact: Victor Dayan, MD, PhD 59899647288 victor_dayan@hotmail.com

Locations
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Uruguay
Centro Cardiovascular Universitario Recruiting
Montevideo, Uruguay
Contact: Victor Dayan, MD, PhD         
Instituto Nacional de Cirugia Cardiaca Recruiting
Montevideo, Uruguay
Contact: Victor Dayan, MD, PhD         
Sponsors and Collaborators
Instituto Nacional de Cirugia Cardiaca, Uruguay
Universidad de la Republica
Investigators
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Principal Investigator: Victor Dayan, MD, PhD Instituto Nacional de Cirugia Cardiaca
Principal Investigator: Diego Freire, MD Centro Cardiovascular Universitario

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Responsible Party: Victor Dayan, Cardiac Surgeon, Instituto Nacional de Cirugia Cardiaca, Uruguay
ClinicalTrials.gov Identifier: NCT03807921     History of Changes
Other Study ID Numbers: ANTIPRO
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: From January 2019
Access Criteria: Protocol will be shared by email. Investigators interested should send email to the PI who will evaluate the solicitude.

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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

Keywords provided by Victor Dayan, Instituto Nacional de Cirugia Cardiaca, Uruguay:
aortic valve replacement
bioprosthesis
anticoagulation

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants