Atrial FibrillationNCT00484640
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
A study testing Coumadin in people with Atrial Fibrillation and Deep Venous Thrombosis, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.
Trial summary
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including the clinical reason for your taking coumadin, your age, gender, your body surface area, and other medical conditions you may have with dosing estimated by a dosing calculator… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrial Fibrillation, Deep Venous Thrombosis, Heart Valve Replacement
- What is being tested?
- Coumadin
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to May 2008
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian male and female patients(including Hispanic white) greater than or equal to 40 years of age;
- Patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
- Target INR of 2 to 3.5;
- Women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.
Who cannot join
- Age less than 40 years;
- Patients of known Native American, Asian, or African descent;
- Patients with thrombocytopenia(platelet count<50x10 cells/ml);
- Patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
- Patients with severe to moderate hepatic insufficiency (AST or ALT less than 2x the upper limit of normal;
- Clinical contraindication for coumadin therapy;
- Female patients with a positive pregnancy test or women who are breastfeeding
Trial locations and contacts
2 sites in 1 country.
Deborah J Hilgemann, Res. Coord. contact
United States2 sites
Third Wave Molecular Diagnostics
Madison, Wisconsin, 53719
Amy Brower, PhD
Marshfield Clinic
Marshfield, Wisconsin, 54449
About this study
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including the clinical reason for your taking coumadin, your age, gender, your body surface area, and other medical conditions you may have with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response. The hypothesis to be tested by this trial states that:when compared to patients managed with a best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will: 1)show reduced risk of adverse events (using surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing.
Read the detailed description
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including clinical reason for taking coumadin, your age, gender, your body surface area, and other medical conditions you may have and dosing with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response. The hypothesis to be tested by this trial states that:when compared to patients managed with a best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will: 1)show reduced risk of adverse events (using surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing
- Being tested
- Coumadin
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoumadinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
weighted time in therapeutic range
absolute deviation from clinically optimal dose
Secondary outcomes (3)
time to stable dose in therapeutic target range
warfarin related adverse drug events
time to first INR above 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startJun 2007
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- Marshfield Clinic Research Foundation
- Investigators
- Michael Caldwell, Physician, Principal investigator, Marshfield Clinic Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484640
- Sponsor's protocol ID
- R01HS016335-01
- Status last verified
- Jun 2007
- First submitted
- 4 Jun 2007
- Last updated
- 11 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hillman MA, Wilke RA, Caldwell MD, Berg RL, Glurich I, Burmester JK. Relative impact of covariates in prescribing warfarin according to CYP2C9 genotype. Pharmacogenetics. 2004 Aug;14(8):539-47. doi: 10.1097/01.fpc.0000114760.08559.dc.
PubMed 15284536Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol. 2005 Jan;20(1):7-14.
PubMed 15596953Wilke RA, Berg RL, Vidaillet HJ, Caldwell MD, Burmester JK, Hillman MA. Impact of age, CYP2C9 genotype and concomitant medication on the rate of rise for prothrombin time during the first 30 days of warfarin therapy. Clin Med Res. 2005 Nov;3(4):207-13. doi: 10.3121/cmr.3.4.207.
PubMed 16303885Hillman MA, Wilke RA, Yale SH, Vidaillet HJ, Caldwell MD, Glurich I, Berg RL, Schmelzer J, Burmester JK. A prospective, randomized pilot trial of model-based warfarin dose initiation using CYP2C9 genotype and clinical data. Clin Med Res. 2005 Aug;3(3):137-45. doi: 10.3121/cmr.3.3.137.
PubMed 16160068
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
- ClinicalTrials.gov ID
- NCT00484640
- Acronym / sponsor ID
- R01HS016335-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- Marshfield Clinic Research Foundation
- Study start
- Jun 2007
- Study completion
- May 2008 (estimated)
- First posted
- 11 Jun 2007 (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.
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including the clinical reason for your taking coumadin, your age, gender, your body surface area, and other medical conditions you may have with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response. The hypothesis to be tested by this trial states that:when compared to patients managed with a best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will: 1)show reduced risk of adverse events (using surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing.
Detailed description
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including clinical reason for taking coumadin, your age, gender, your body surface area, and other medical conditions you may have and dosing with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response. The hypothesis to be tested by this trial states that:when compared to patients managed with a best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will: 1)show reduced risk of adverse events (using surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian male and female patients(including Hispanic white) greater than or equal to 40 years of age;
- Patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
- Target INR of 2 to 3.5;
- Women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.
Key exclusion criteria (7 listed)
- Age less than 40 years;
- Patients of known Native American, Asian, or African descent;
- Patients with thrombocytopenia(platelet count<50x10 cells/ml);
- Patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
- Patients with severe to moderate hepatic insufficiency (AST or ALT less than 2x the upper limit of normal;
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 |
|---|---|---|
| Coumadin | Drug | – |
Primary outcome
weighted time in therapeutic range
absolute deviation from clinically optimal dose
3 secondary outcomes
time to stable dose in therapeutic target range
warfarin related adverse drug events
time to first INR above 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2007.
- Background: PubMed 15284536Hillman MA, Wilke RA, Caldwell MD, Berg RL, Glurich I, Burmester JK. Relative impact of covariates in prescribing warfarin according to CYP2C9 genotype. Pharmacogenetics. 2004 Aug;14(8):539-47. doi: 10.1097/01.fpc.0000114760.08559.dc.
- Background: PubMed 15596953Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol. 2005 Jan;20(1):7-14.
- Background: PubMed 16303885Wilke RA, Berg RL, Vidaillet HJ, Caldwell MD, Burmester JK, Hillman MA. Impact of age, CYP2C9 genotype and concomitant medication on the rate of rise for prothrombin time during the first 30 days of warfarin therapy. Clin Med Res. 2005 Nov;3(4):207-13. doi: 10.3121/cmr.3.4.207.
- Background: PubMed 16160068Hillman MA, Wilke RA, Yale SH, Vidaillet HJ, Caldwell MD, Glurich I, Berg RL, Schmelzer J, Burmester JK. A prospective, randomized pilot trial of model-based warfarin dose initiation using CYP2C9 genotype and clinical data. Clin Med Res. 2005 Aug;3(3):137-45. doi: 10.3121/cmr.3.3.137.
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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.
Deborah J Hilgemann, Res. Coord. contact
Michael Caldwell, Physician principal investigator
Marshfield Clinic Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coumadin in people with Atrial Fibrillation and Deep Venous Thrombosis, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.
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 4 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 11 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Contact Deborah J Hilgemann, Res. Coord. (715-389-3774 ext. same, hilgemann.deborah@marshfieldclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weighted time in therapeutic range. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484640, which also lists 4 linked publications.
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 11 Jun 2007.