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Rivaroxaban or Aspirin for Biological Aortic Prosthesis

NCT02974920 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2018-06-27

No results posted yet for this study

Summary

Aortic valve replacement with a biological prosthesis is the most common valve surgery performed with about 1000 operations performed in Denmark each year. Further, the introduction of percutaneous stent valves will increase these types of replacements in the years to come. A biological valve is a foreign body prone to cause thrombus formation at least until the valve is covered with recipient endothelium. There are no conclusive studies of anticoagulation and the investigators have shown stroke to be a common complication. Guidelines have variably recommended aspirin or rivaroxaban for anticoagulation, and currently aspirin is the most common recommendation. In a register study, the investigators have shown that proper anticoagulation with warfarin is likely to be superior. There is a clear need for a large randomised study of aspirin versus anticoagulation for biological aortic valve replacement. This protocol describes a randomised study where 1000 patients will be randomised to receive either rivaroxaban or aspirin for 6 months following aortic valve replacement with a biological prosthesis. The primary efficacy endpoint is a combined event of all-cause mortality and hospitalisation for either acute myocardial infarction or stroke. This study has the power to settle a discussion of appropriate anticoagulation for this operation

Conditions

Interventions

DRUG

Rivaroxaban 10 MG

Rivaroxaban 10 mg once daily for 180 days

DRUG

Aspirin

Aspirin 100 mg once daily for 180 days

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Christian Torp-Pedersen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2022-11-01
Completion
2022-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

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 NCT02974920 on ClinicalTrials.gov