Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. (CATHAR)
To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major complications in patients undergoing a mechanical aortic heart valve replace-ment.
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
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.
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.
Aortic Valve Disease
Heart Valve Prosthesis Implantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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.|
- All cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with prosthetic thrombus [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with major bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with ischemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with stroke [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with embolism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with myocardial infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: All patients
CATHAR is a prospective, open-label, pilot, phase 2 study with independent evaluation of all outcomes. The trial is based on a Bayesian design by incorporating historical information for the control group for all analyses.
Direct Factor Xa Inhibitor
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02128841
|Contact: Eva Roost, MD||+41 31 632 firstname.lastname@example.org|
|Dep. of Cardiovascular Surgery, Berne University Hospital||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Eva Roost, MD +41 31 632 7848 email@example.com|
|Principal Investigator: Eva Roost, MD|
|Principal Investigator:||Eva Roost, MD||Department of cardiovascular surgery, University Hospital Berne, Switzerland|