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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02128841
First received: April 24, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Aortic Valve Disease
Heart Valve Prosthesis Implantation
Anticoagulants
Drug: Rivaroxaban
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128841

Contacts
Contact: Alberto Weber, MD +41316329072 alberto.weber@insel.ch

Locations
Switzerland
Dep. of Cardiovascular Surgery, Berne University Hospital Recruiting
Bern, Switzerland, 3010
Contact: PD Dr. med. Weber Alberto, MD    +41316329072    alberto.weber@insel.ch   
Principal Investigator: Alberto Weber, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Alberto Weber, MD Department of cardiovascular surgery, University Hospital Berne, Switzerland
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02128841     History of Changes
Other Study ID Numbers: 154/10, 2011DR2223
Study First Received: April 24, 2014
Last Updated: April 29, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014