WarfarinPhase 4NCT00735189
Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician?
A Phase 4 study testing anticoagulation clinic care in people with Warfarin, run by University of Alberta at 1 site in Canada.
Trial summary
Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warfarin
- What is being tested?
- anticoagulation clinic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Apr 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current patient of the Anticoagulation Management Service
- anticipated need for long term anticoagulation
- have a regular primary care physician
Who cannot join
- previous failure of warfarin therapy (a bleed or clot despite therapeutic anticoagulation
- have a planned procedure (surgery) mandating discontinuation of warfarin
- are taking warfarin for a mechanical valve indication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician? A Prospective Randomized Trial
Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the degree of blood thinning is kept within a narrow window - if the blood is "too thick" clots may form but if the blood is "too thin" the risk of bleeding increases. Complicating the control of warfarin is that different people require different amounts of it to have an appropriate degree of blood thinning, and once this amount is determined for a patient, it may be changed by factors that are encountered on a daily basis (i.e., diet, acute and chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has demonstrated really good control of blood thinning therapy by working with patients to inform them of the rationale for this medicine, the factors having the ability to impact its control, and encouraging the patient to be involved in their care (via provision of tools to document test results, one-on-one education and access to our program at any time with questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource limitations. As such, it is imperative that we investigate alternate strategies to manage these patients. Paramount, however, is that any long-term strategy must not confer inferior control of warfarin. The purpose of this study is to determine if the impact of AMS Care is sustained following the transfer of anticoagulation management to the family doctor. Operationally, the results of this study will guide future management of patients. If control of warfarin therapy declines with family doctor management, alternate strategies, such as patient self-management, will need to be investigated in a larger scale trial.
- Conditions
- Warfarin
- Being tested
- anticoagulation clinic care, usual care
- Keywords
- warfarin, anticoagulation, anticoagulation clinics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulation clinic careOther
Patient receives care from the outpatient anticoagulation management service
usual careOther
patient receives usual anticoagulation care from their regular primary care physician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient continues to receive anticoagulation care from the Anticoagulation Management Service Receives: Other: anticoagulation clinic care |
| 2 | Active comparator | Patient receives anticoagulation care from their usual primary care physician Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.
Measured: 6 months
Secondary outcomes (5)
Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method
Measured: 6 months
Rates of thrombosis between groups
Measured: 6 months
Rates of major hemorrhage between groups
Measured: 6 months
Patient satisfaction via postal survey
Measured: 6 months
Rate of crossover from primary care physician group back to anticoagulation management service
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionApr 2010
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.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Tammy J Bungard, PharmD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735189
- Sponsor's protocol ID
- epicore ams1
- Status last verified
- Jun 2010
- First submitted
- 12 Aug 2008
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician? A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00735189
- Acronym / sponsor ID
- epicore ams1
- Conditions
- Warfarin
- Keywords
- warfarin, anticoagulation, anticoagulation clinics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Aug 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.
Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the degree of blood thinning is kept within a narrow window - if the blood is "too thick" clots may form but if the blood is "too thin" the risk of bleeding increases. Complicating the control of warfarin is that different people require different amounts of it to have an appropriate degree of blood thinning, and once this amount is determined for a patient, it may be changed by factors that are encountered on a daily basis (i.e., diet, acute and chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has demonstrated really good control of blood thinning therapy by working with patients to inform them of the rationale for this medicine, the factors having the ability to impact its control, and encouraging the patient to be involved in their care (via provision of tools to document test results, one-on-one education and access to our program at any time with questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource limitations. As such, it is imperative that we investigate alternate strategies to manage these patients. Paramount, however, is that any long-term strategy must not confer inferior control of warfarin. The purpose of this study is to determine if the impact of AMS Care is sustained following the transfer of anticoagulation management to the family doctor. Operationally, the results of this study will guide future management of patients. If control of warfarin therapy declines with family doctor management, alternate strategies, such as patient self-management, will need to be investigated in a larger scale trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: anticoagulation clinic carePatient continues to receive anticoagulation care from the Anticoagulation Management Service |
| 2 | Active comparator | Other: usual carePatient receives anticoagulation care from their usual primary care physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current patient of the Anticoagulation Management Service
- anticipated need for long term anticoagulation
- have a regular primary care physician
Key exclusion criteria (3 listed)
- previous failure of warfarin therapy (a bleed or clot despite therapeutic anticoagulation
- have a planned procedure (surgery) mandating discontinuation of warfarin
- are taking warfarin for a mechanical valve indication
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 |
|---|---|---|
| anticoagulation clinic carePatient receives care from the outpatient anticoagulation management service | Other | 1 |
| usual carepatient receives usual anticoagulation care from their regular primary care physician | Other | 2 |
Primary outcome
Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.
Time frame: 6 months
5 secondary outcomes
Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method
Time frame: 6 months
Rates of thrombosis between groups
Time frame: 6 months
Rates of major hemorrhage between groups
Time frame: 6 months
Patient satisfaction via postal survey
Time frame: 6 months
Rate of crossover from primary care physician group back to anticoagulation management service
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
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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.
Tammy J Bungard, PharmD principal investigator
University of Alberta
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 anticoagulation clinic care in people with Warfarin, run by University of Alberta at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 24 Jun 2010. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method. (time frame: 6 months). 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 24 Jun 2010.