Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antith… (NCT02128841) | Clinical Trial Compass
TerminatedPhase 2
Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.
Stopped: not enough patients
Switzerland12 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 × 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.