Benefit of Self-monitoring of Anticoagulation Instrument

Study acronym: 4A
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Interventions: Conventional follow-up of anti-coagulation (Device), INRatio / Coaguchek XS (Device) to INRatio / Coaguchek XS (Device)
    • Collaborators revised (3)
    v4
  2. 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
    v3
  3. Primary completion date: Jun 2009v2 Show 4 more changesShow less
    • Study 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
    • Study arms: 0 to 2
  4. Study First Submitted
  • 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
(from sponsor)		 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