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Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

NCT01452568 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2014-08-05

No results posted yet for this study

Summary

The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.

The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.

Conditions

Interventions

DRUG

Aspirin

150mg/daily for three months, starting day after surgery

DRUG

Warfarin

Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Peter S Olsen, MD, DMSc · Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

  • Nikolaj B Lilleør · Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

  • Sulman Rafiq · Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452568 on ClinicalTrials.gov