NCT03807921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

January 15, 2019

Last Update Submit

February 21, 2022

Conditions

Aortic Valve StenosisAortic Valve DiseaseAortic Valve InsufficiencyAortic Valve Regurgitation

Keywords

aortic valve replacementbioprosthesisanticoagulation

Outcome Measures

Primary Outcomes (2)

  • Transprosthetic aortic gradient

    Change in Transprosthetic mean gradient

    3 months and 1 year

  • Change in New York Heart Association (NYHA) class

    NYHA class

    1 year

Secondary Outcomes (3)

  • Major bleeding

    3 months and 1 year

  • Embolic events

    3 months and 1 year

  • Prosthetic leak

    3 months and 1 year

Study Arms (2)

Warfarin

EXPERIMENTAL

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: WarfarinDrug: Aspirin

Aspirin only

ACTIVE COMPARATOR

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

Interventions

WarfarinDRUG

Oral anticoagulation

Also known as: Choice
Warfarin
AspirinDRUG

Antiplatelet treatment

Also known as: AAS
Aspirin onlyWarfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with indication of aortic valve replacement with porcine bioprosthesis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Cardiovascular Universitario

Montevideo, Uruguay

Location

Instituto Nacional de Cirugia Cardiaca

Montevideo, Uruguay

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve DiseaseAortic Valve Insufficiency

Interventions

WarfarinAspirin

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Victor Dayan, MD, PhD

    Instituto Nacional de Cirugia Cardiaca

    PRINCIPAL INVESTIGATOR

  • Diego Freire, MD

    Centro Cardiovascular Universitario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac Surgeon

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 17, 2019

Study Start

January 1, 2019

Primary Completion

December 30, 2019

Study Completion

December 31, 2019

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Study protocol.

Shared Documents
STUDY PROTOCOL, 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.

Locations

UR(2)