Rivaroxaban or Aspirin for Biological Aortic Prosthesis
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Christian Torp-Pedersen
Collaborators:
Aalborg Universitetshospital Aalborg University Hospital Aarhus University Hospital Odense University Hospital Rigshospitalet, Denmark