Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.

• Status: Terminated
• Trial end date: 2017-09-01

Summary

Objectives

Primary objective:

To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major complications in patients undergoing a mechanical aortic heart valve replace-ment.

Secondary objectives:

To identify the value of molecular markers suitable for monitoring of anticoagulation effectiveness of rivaroxaban and its correlation with transcranial Doppler emboli count in patients undergoing a mechanical aortic heart valve replacement.

Design This is a prospective, open-label phase 2 pilot study with independent evaluation of all outcomes and a historical control group.

Number of patients 30 in experimental group (patients in the center's registry database serve as control group).

Main eligibility criteria All patients between 18 and 70 years old receiving a mechanical aortic valve replacement with a pre-operative left ventricular ejection fraction >/=35%.

Interventions Experimental: Rivaroxaban 20mg p.o., once daily, for six months Historical control: Phenprocoumon (Marcoumar) p.o., once daily Outcomes

Primary outcome:

Composite outcome of prosthetic thrombus requiring reoperation/intervention, major bleeding, visceral ischemia, stroke, pulmonary embolism, myocardial infarction or death from any cause 180 days after intervention.

Secondary outcomes:

Each component of the composite outcome plus serious adverse events. Prosthetic thrombus requiring reoperation/intervention plus non-clinically relevant thrombi will be used as an additional safety outcome.

Molecular markers suitable for monitoring the effectiveness of rivaroxaban.

• Phase: Phase 2

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Rivaroxaban