ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128841
Recruitment Status : Terminated (not enough patients)
First Posted : May 1, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.


Condition or disease Intervention/treatment Phase
Aortic Valve Disease Heart Valve Prosthesis Implantation Anticoagulants Drug: Rivaroxaban Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Actual Study Start Date : September 2012
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
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.
Drug: Rivaroxaban
Direct Factor Xa Inhibitor




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of patients with prosthetic thrombus [ Time Frame: 6 months ]
  2. Number of patients with major bleeding [ Time Frame: 6 months ]
  3. Number of patients with ischemia [ Time Frame: 6 months ]
  4. Number of patients with stroke [ Time Frame: 6 months ]
  5. Number of patients with embolism [ Time Frame: 6 months ]
  6. Number of patients with myocardial infarction [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128841


Locations
Switzerland
Dep. of Cardiovascular Surgery, Berne University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Eva Roost, MD Department of cardiovascular surgery, University Hospital Berne, Switzerland

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02128841     History of Changes
Other Study ID Numbers: 154/10
2011DR2223 ( Other Identifier: Swissmedic )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by University Hospital Inselspital, Berne:
rivaroxaban
Heart Valve Prosthesis Implantation
anticoagulants
Factor Xa/antagonists & inhibitors

Additional relevant MeSH terms:
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants