Anticoagulation for Aortic Bioprosthesis (ANTIPRO) | NCT03807921

Studies
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

NCT03807921

Sponsor

Instituto Nacional de Cirugia Cardiaca, Uruguay

Status

Completed

Last Update Posted

Mar 8, 2022Actual

Enrollment

140Actual

Phase

Phase 4

Conditions

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

Interventions

Warfarin
Aspirin

Countries

Uruguay

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jan 15, 2019

First Submission Date that Met QC Criteria

Jan 16, 2019

First Posted Date

Jan 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2022

Last Update Posted Date

Mar 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Victor Dayan, Cardiac Surgeon, Instituto Nacional de Cirugia Cardiaca, UruguayPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cirugia Cardiaca, UruguayOTHER

Collaborators

Name	Class
Universidad de la Republica	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Warfarin Drug: 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

Name	Type	Description	Arm Group Labels	Other Names
Warfarin	Drug	Oral anticoagulation	Warfarin	Choice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Major bleeding	number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion	3 months and 1 year
Embolic events	Number of patients with cerebral and peripheral ischemic events

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Victor Dayan, MD, PhD	Instituto Nacional de Cirugia Cardiaca	Principal Investigator
Diego Freire, MD	Centro Cardiovascular Universitario	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Cardiovascular Universitario		Montevideo			Uruguay
Instituto Nacional de Cirugia Cardiaca

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol.

Types

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis
D000082862	Aortic Valve Disease
D001022	Aortic Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014859	Warfarin
D001241	Aspirin

Ancestor Terms

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573

Browse Leaves

Not provided

Browse Branches

Not provided