Overview

This trial is active, not recruiting.

Condition warfarin
Treatments coaguchek (patient self testing), anticoagulation management service (ams)
Phase phase 4
Sponsor University College Cork
Collaborator Hoffmann-La Roche
Start date July 2006
End date April 2009
Trial size 163 participants
Trial identifier NCT00594828, PA/05/16

Summary

To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional outpatient anticoagulation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
6 months of supervised patient self testing using an expert system
coaguchek (patient self testing) CoaguChek S point of care meter
Patients will test their INR at home either biweekly, weekly or every 2 weeks using a CoaguChek point of care meter and communicate with the healthcare provider via an internet based expert system
(Active Comparator)
6 months of routine medical care by the anticoagulation management service
anticoagulation management service (ams)
Patients will attend the AMS for six months and have their INR checked every 4-6 weeks or more frequently, at the discretion of the clinician

Primary Outcomes

Measure
The primary outcome variable used to assess therapeutic efficacy and safety will be the difference in TTR during the six months of AMS management and the six months of PST
time frame: 1 year

Secondary Outcomes

Measure
To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - on warfarin therapy for a minimum of 2 months - are expected to be on warfarin therapy for the duration of the 12 month study - internet access Exclusion Criteria: - inability to provide informed consent - inability to use a home INR meter - patients who do not have a telephone - more than 2 missed clinic appointments in the preceding 6 months - patients on anticoagulant drugs other than warfarin (eg heparin, low molecular weight heparin) - history of hemorrhagic complications with a therapeutic or therapeutic INR in the preceding 6 months - inability to attend the hospital at short notice, if necessary

Additional Information

Official title Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System
Principal investigator Susan J O'Shea, MD
Description Indications for anticoagulant treatment to prevent thromboembolic disease have increased in recent years. INR must be monitored frequently to determine the safest dose and to minimize the risk for thrombotic and haemorrhagic complications. Standard warfarin therapy is associated with rates of major haemorrhage of up to 5-9% annually and recurrent venous thromboembolism of up to 8%. These event rates are dependent of the model of care used to manage warfarin therapy, with better outcomes associated with home testing of the INR which enables patients to monitor their response to warfarin more frequently. INR results must still be 'managed' by communicating the data to the healthcare provider, usually be telephone or fax. In this study we will evaluate a novel method of PST; supervised PST with an internet based expert system, which 'manages' patients on oral anticoagulation by utilizing clinical and laboratory data provided by the patient and dose adjustment and retesting algorithms derived from clinical practice. Patients will be randomized to either 6 months of supervised PST or routine medical care by the AMS. At the end of the 6 month period, each patient will then 'cross over' to the other management regimen and the difference in TTR between the two periods will be compared.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by University College Cork.