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Benefit of Self-monitoring of Anticoagulation Instrument

NCT00506870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 919

Last updated 2010-12-14

No results posted yet for this study

Summary

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.

Conditions

  • Mechanical Prosthetic Heart Valve Implantation
  • Patient Self Monitoring of Oral Anticoagulent Therapy

Interventions

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.

DEVICE

Conventional follow-up of anti-coagulation

At least, one follow-up of INR per month. Measured in laboratory.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Biodis

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Raymond ROUDAUT, Pr · University Hospital, Bordeaux

  • Geneviève CHENE, Pr · University Hospital, Bordeaux

  • Raymond ROUDAUT, Pr · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • France

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00506870 on ClinicalTrials.gov