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Benefit of Self-monitoring of Anticoagulation Instrument

Study acronym: 4A
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Interventions: Conventional follow-up of anti-coagulation (Device), INRatio / Coaguchek XS (Device) to INRatio / Coaguchek XS (Device)

    Collaborators revised (3)

    Show what changed: Collaborators
    Hoffmann-LaRoche RocheDiagnostics GmbH

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Arms and Interventionsv4

  2. Notable

    Primary and study completion dates changed from estimate of Jun 2009 to Feb 2010

    Trial status: Recruiting to Completed; Enrollment target: estimated 1050 to confirmed 919; Site details revised

    Study Identification, Study Status, Study Design, Contacts/Locationsv3

  3. Minor

    Primary completion date: Jun 2009

    Completion date: Dec 2009 to Jun 2009; Interventions: Coaguchek XS (Device), INRatio (Device) to Conventional follow-up of anti-coagulation (Device), INRatio / Coaguchek XS (Device); Secondary endpoints: details revised at 2 of 3 entries; and 1 more

    Show all 5 changes in this update
    • Minor Primary completion date: Jun 2009
    • Minor Completion date: Dec 2009 to Jun 2009
    • Minor Interventions: Coaguchek XS (Device), INRatio (Device) to Conventional follow-up of anti-coagulation (Device), INRatio / Coaguchek XS (Device)
    • Minor Secondary endpoints: details revised at 2 of 3 entries
    • Minor Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measuresv2

  4. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00506870
Lead Sponsor University Hospital, Bordeaux
Collaborators: Ministry of Health, France, Roche Diagnostics GmbH, Biodis
Conditions Mechanical Prosthetic Heart Valve Implantation, Patient Self Monitoring of Oral Anticoagulent Therapy
Enrollment 919 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov