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

NCT02128841 | Terminated Phase 2 DMC

• 2 other identifiers: 154/102011DR2223
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease; Heart Valve Prosthesis Implantation; Anticoagulants

Keywords

rivaroxaban; Heart Valve Prosthesis Implantation; anticoagulants; Factor Xa/antagonists & inhibitors

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  6 months

Secondary Outcomes (6)

• Number of patients with prosthetic thrombus

  6 months

• Number of patients with major bleeding

  6 months

• Number of patients with ischemia

  6 months

• Number of patients with stroke

  6 months

• Number of patients with embolism

  6 months

Study Arms (1)

All patients

EXPERIMENTAL

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

Interventions

Rivaroxaban DRUG

Direct Factor Xa Inhibitor

All patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Cardiovascular Surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 23991661 BACKGROUND

• Roost E, Weber A, Alberio L, Englberger L, Reineke D, Keller D, Nagler M, Carrel T. Rivaroxaban in patients with mechanical heart valves: A pilot study. Thromb Res. 2020 Feb;186:1-6. doi: 10.1016/j.thromres.2019.12.005. Epub 2019 Dec 7.

  PMID: 31837559 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eva Roost, MD

  Department of cardiovascular surgery, University Hospital Berne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 1, 2014
• Study Start: September 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

CH (1)