CompletedPhase 3

Patient International Normalised Ratio (INR) Self-Testing Program

206 participantsStarted 2004-05

Plain-language summary

The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * able to be followed up during 12 months Exclusion Criteria: * refusal of participation in the study * Participation in another clinical study * Patient is pregnant or nursing * Life expectancy less than three months * Contra-indication of to an A.V.K treatment * Difficult comprehension of the French language * Patients unable to master the self-monitoring procedures * Individuals under judicial control or enquiry * Patients on dialysis Patients with incomplete understanding of instructions * Blind patients and those unable to read

What they're measuring

Hemorrhagic events and thromboembolic events

Timeframe: after mechanical heart valve replacement

Trial details

NCT IDNCT00925197

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-09

View on ClinicalTrials.gov More Mechanical Aortic and/or Mitral Valve Replacement Operation trials