Benefit of Self-monitoring of Anticoagulation Instrument (4A)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Hoffmann-La Roche
Biodis
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00506870
First received: July 23, 2007
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.


Condition Intervention
Mechanical Prosthetic Heart Valve Implantation
Patient Self Monitoring of Oral Anticoagulent Therapy
Device: INRatio / Coaguchek XS
Device: Conventional follow-up of anti-coagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Economic and Medical Evaluation of Self-monitoring of Anticoagulation in a Population of Patients Recently Fitted With a Mechanical Heart Valve Compared to Conventional Anticoagulation Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death) within a population recently fitted with a mechanical hear valve. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the proportion of monthly measurements of INR within the designated range [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • the inherent cost of each strategy of anticoagulation monitoring [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment: 919
Study Start Date: June 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Conventional follow-up of anticoagulation
Device: Conventional follow-up of anti-coagulation
At least, one follow-up of INR per month. Measured in laboratory.
Experimental: 2
Self-monitoring of anticoagulation
Device: INRatio / Coaguchek XS
INR measured by patient himself using INRation or Coaguchek device. And one follow-up of INR per month, measured in laboratory.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults
  • patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
  • oral anticoagulant treatment
  • patients with social security cover
  • written informed consent signed by both patient and investigator

Exclusion Criteria:

  • women pregnant or liable to become pregnant during the study
  • nursing women
  • patients unable to master the self-monitoring procedures
  • individuals under judicial control or enquiry
  • patients consuming excessive amounts of alcohol ((>40g/j for men et >30g/j for women femmes ; 1 glass = 10g)
  • patients on dialysis
  • patients with incomplete understanding of instructions
  • blind patients and those unable to read
  • presence of circulating anticoagulant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506870

Locations
France
Pôle Cardio-Thoracique - Hôpital Cardiologique du Haut-Lévêque - CHU de Bordeaux - Avenue de Magellan
PESSAC Cedex, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Hoffmann-La Roche
Biodis
Investigators
Study Director: Raymond ROUDAUT, Pr University Hospital, Bordeaux
Study Chair: Geneviève CHENE, Pr University Hospital, Bordeaux
Principal Investigator: Raymond ROUDAUT, Pr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00506870     History of Changes
Other Study ID Numbers: CHUBX2006/04, 2006/019
Study First Received: July 23, 2007
Last Updated: December 13, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Heart Valve Prosthesis Implantation
INR self monitoring
cost benefit evaluation

ClinicalTrials.gov processed this record on April 17, 2014