Patient Self Testing of Warfarin Therapy

Warfarin Clinical Trial

Official title:

Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00594828
• Other study ID #: PA/05/16
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 7, 2008
• Last updated: January 7, 2008
• Start date: July 2006
• Est. completion date: April 2008

Study information

• Verified date: January 2008
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines BoardIreland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: April 2008
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Warfarin

Intervention

Device:
• CoaguChek (Patient self testing)
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
• 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

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork

Sponsors (4)

Lead Sponsor	Collaborator
University College Cork	Health Research Board, Ireland, Hoffmann-La Roche, ZyCare Inc

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year	Yes
Secondary	To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management		1 year	Yes