WarfarinPhase 4NCT00594828
Patient Self Testing of Warfarin Therapy
A Phase 4 study testing CoaguChek (Patient self testing) and Anticoagulation Management Service (AMS) in people with Warfarin, run by University College Cork at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Warfarin
- What is being tested?
- CoaguChek (Patient self testing) and Anticoagulation Management Service (AMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2006to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System
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.
Read the detailed 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.
- Conditions
- Warfarin
- Being tested
- CoaguChek (Patient self testing), Anticoagulation Management Service (AMS)
- Keywords
- Patient self-testing, Oral anticoagulation therapy, Expert Systems, Point-of-Care Systems, International Normalized Ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoaguChek (Patient self testing)Device
Also called CoaguChek S point of care meter, CoaguChek XS point of care meter, CoagCare expert system
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)Device
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 months of supervised patient self testing using an expert system Receives: Device: CoaguChek (Patient self testing) |
| 2 | Active comparator | 6 months of routine medical care by the anticoagulation management service Receives: Device: Anticoagulation Management Service (AMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJul 2006
- Primary completionApr 2009 (estimated)
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WarfarinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Health Research Board, Ireland, ZyCare Inc
- Investigators
- Susan J O'Shea, MD, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594828
- Sponsor's protocol ID
- PA/05/16
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System
- ClinicalTrials.gov ID
- NCT00594828
- Acronym / sponsor ID
- PA/05/16
- Conditions
- Warfarin
- Keywords
- Patient self-testing, Oral anticoagulation therapy, Expert Systems, Point-of-Care Systems, International Normalized Ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Health Research Board, Ireland, ZyCare Inc
- Study start
- Jul 2006
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2008 (estimated)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CoaguChek (Patient self testing)6 months of supervised patient self testing using an expert system |
| 2 | Active comparator | Device: Anticoagulation Management Service (AMS)6 months of routine medical care by the anticoagulation management service |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoaguChek (Patient self testing)Also: CoaguChek S point of care meter, CoaguChek XS point of care meter, CoagCare expert systemPatients 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 | Device | 1 |
| 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 | Device | 2 |
Primary outcome
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
1 secondary outcome
To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J O'Shea, MD principal investigator
Cork University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CoaguChek (Patient self testing) and Anticoagulation Management Service (AMS) in people with Warfarin, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2008.