Patient International Normalised Ratio (INR) Self-Testing... | NCT00925197

Studies
Patient International Normalised Ratio (INR) Self-Testing Program

NCT00925197

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Jun 22, 2009Estimated

Enrollment

206Actual

Phase

Phase 3

Conditions

Mechanical Aortic and/or Mitral Valve Replacement Operation

Interventions

INR self-testing program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Sep 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jun 18, 2009

First Submission Date that Met QC Criteria

Jun 19, 2009

First Posted Date

Jun 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2009

Last Update Posted Date

Jun 22, 2009Estimated

Name	Class
Abbott Medical Devices	INDUSTRY
Roche Diagnostics GmbH	INDUSTRY
HemoSense	INDUSTRY

Description Module

Brief 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.

Detailed Description

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

206Actual

Name	Type	Description	Arm Group Labels	Other Names
INR self-testing program	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemorrhagic events and thromboembolic events		after mechanical heart valve replacement

Secondary Outcomes

Measure	Description	Time Frame
Correlation of laboratory INR and device INR control		after mechanical heart valve replacement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kasra Azarnoush, MD	University Hospital, Clermont-Ferrand	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24112749	Derived	Azarnoush K, Dorigo E, Pereira B, Dauphin C, Geoffroy E, Dauphin N, D'Ostrevy N, Legault B, Camilleri L. Mid-term results of self-testing of the international normalized ratio in adults with a mechanical heart valve. Thromb Res. 2014 Feb;133(2):149-53. doi: 10.1016/j.thromres.2013.09.013. Epub 2013 Sep 16.