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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• All patients receiving a mechanical aortic valve replacement. This includes also the following combined procedures:

• Coronary artery bypass

• Composite graft

• Coronary re-implantation

• Aortic root, ascending aorta, arch or hemi-arch replacement

• Redo surgery

• Aortic root enlargement

• Three days after end of the primary aortic valve surgery: no mechanical ventilation in the last 12 hours

• Left ventricular ejection fraction >/=30% preoperative.

• Written informed consent

Exclusion Criteria

• Contraindication to Phenprocoumon or rivaroxaban treatment.

• Premenopausal and fertile women (menopause defined as 1 year free of period)

• Mitral valve surgery

• Aneurysmectomy

• Maze ablation

• Peripheral vascular surgery

• Aortic type A or B dissection

• Patients following mitral valve replacement

• Patients in need of platelets inhibitors other than Aspirin.

• Active infective endocarditis

• Preoperative atrial fibrillation

• Myocardial infarction or percutaneous coronary intervention within 6 months prior to start of rivaroxaban

• Stroke within 6 months prior to start of rivaroxaban

• Systemic embolism within 6 months prior to start of rivaroxaban

• Severe renal impairment (estimated creatinine clearance ≤30 mL/min)

• Conditions associated with an increased risk of bleeding within 6 months prior to start of rivaroxaban:

• Active liver disease, including but not limited to

• Anemia (hemoglobin level <85g/L) or thrombocytopenia (platelet count <100 × 109/L)

• Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study

• Patients considered unreliable by the investigator