Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03807921
Study type	Interventional
Source	Instituto Nacional de Cirugia Cardiaca, Uruguay
Contact
Status	Completed
Phase	Phase 4
Start date	January 1, 2019
Completion date	December 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03186339` - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Terminated	`NCT02854319` - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System	N/A
Recruiting	`NCT05601453` - The ReTAVI Prospective Observational Registry
Withdrawn	`NCT05481814` - CPX in Paradoxical Low Flow Aortic Stenosis
Completed	`NCT02241109` - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity	N/A
Completed	`NCT01700439` - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve	N/A
Recruiting	`NCT04429035` - SLOW-Slower Progress of caLcificatiOn With Vitamin K2	N/A
Completed	`NCT04103931` - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis	N/A
Completed	`NCT03950440` - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting	`NCT02661451` - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)	N/A
Completed	`NCT02847546` - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation	N/A
Completed	`NCT02792452` - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed	`NCT02758964` - Evaluation of Cerebral Thrombembolism After TAVR
Not yet recruiting	`NCT02536703` - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population	Phase 3
Not yet recruiting	`NCT02541877` - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve	Phase 3
Active, not recruiting	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Active, not recruiting	`NCT02080299` - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation	Phase 2
Terminated	`NCT01939678` - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease