Aortic Valve Disease Clinical Trial
— CATHAROfficial title:
This is a Prospective, Open-label Phase 2 Pilot Study With Independent Evaluation of All Outcomes and a Historical Control Group to Determine if Rivaroxaban (Xarelto) is Feasible and Safe for Prevention of Major Complications in Patients Undergoing a Mechanical Aortic Heart Valve Replacement.
Verified date | November 2017 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Cardiovascular Surgery, Berne University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All cause mortality | 6 months | ||
Secondary | Number of patients with prosthetic thrombus | 6 months | ||
Secondary | Number of patients with major bleeding | 6 months | ||
Secondary | Number of patients with ischemia | 6 months | ||
Secondary | Number of patients with stroke | 6 months | ||
Secondary | Number of patients with embolism | 6 months | ||
Secondary | Number of patients with myocardial infarction | 6 months |
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