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

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
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: 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 October 23, 2014