Patient International Normalised Ratio (INR) Self-Testing Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Benefit of Self-monitoring of Anticoagulation Instrument

NCT00506870

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

COMPLETED NA

Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management

NCT01269905

Anticoagulation Mechanical Heart Valve Replacement

COMPLETED

Outcome, Recuperation and Hemodynamics in Aortic Stenosis

NCT05272020

Aortic Valve Stenosis

UNKNOWN NA

Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery

NCT04785885

Transcatheter Aortic Valve Replacement Cardiac Valve Annuloplasty

UNKNOWN

The Dutch Asymptomatic Mitral Regurgitation Trial

NCT01708265

Heart; Disease, Mitral(Valve) Diseases of Mitral Valve Mitral Valve Insufficiency

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is the first French, prospective, randomised, single centre study, comparing patient self-testing (PST) of international normalised ratio (INR), with conventional laboratory monitoring. Aims of the study are to prove correlation between laboratory and PST measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.

Patients (206) were postoperatively, randomly, consecutively included (2004 - 2008): 103 patients in each group, with a one year follow-up. Two INR control devices were selected: Coaguchek® (Roche) and INRATIO® (Hemosense).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Aortic and/or Mitral Valve Replacement Operation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INR self-testing program

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No