The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings
NCT ID: NCT00830570
Last Updated: 2010-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1635 participants
OBSERVATIONAL
2007-07-31
2010-01-31
Brief Summary
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Detailed Description
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It is hypothesized that evaluation of genomic allelic type guided warfarin dosing will reduce thromboembolic and bleeding risks associated with warfarin therapy, and that adoption of a genetic testing strategy in a primary patient care setting would improve warfarin effectiveness and patient safety, and reduce costs to health care payers.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Historical control group. Patients in this group are drawn from the same plan populations as the intervention group, but they are identified during the 1-year period prior to the start of patient enrollment in the intervention group. The historical control group is closely matched with the intervention group on demographic characteristics, practice patterns, and benefit plan features that may affect resource utilization.
No interventions assigned to this group
2
Concurrent control group. Patients in this group are drawn from different set of plan populations, but they initiate warfarin treatment during the same time period as patients in the intervention group. Outcomes data for the concurrent control group will be used to evaluate whether any differences between the intervention group and the historical control group can be attributed to changes in clinical practice over time. Baseline data for the concurrent control group will help validate the incidence assumptions used in the calculation of statistical power. This use of baseline population norms is an effective means of limiting bias in quasi-experimental studies.
No interventions assigned to this group
3
Active study group. For plans participating in the active arm of the study, enrollment is offered to every patient who initiates warfarin therapy during the enrollment period (beginning in July 2007) and who meets the eligibility criteria. Patients are identified for the active study group if they have a warfarin pharmacy claim and no prior warfarin claims during the preceding 180 days. Only patients who remain eligible for the pharmacy benefit throughout the study period are included in the final sample.
CYP 2C9 and VKORC1 Testing for Warfarin
Test patients for their warfarin sensitivity and provide this information to their physician authorizing the test.
Interventions
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CYP 2C9 and VKORC1 Testing for Warfarin
Test patients for their warfarin sensitivity and provide this information to their physician authorizing the test.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are in the induction phase of warfarin
* Patients receiving warfarin to prevent or treat thromboembolic conditions (e.g., post orthopedic surgery prophylaxis, deep venous thrombosis, atrial fibrillation, pulmonary embolism, heart failure)
* Patient willing to provide informed consent prior to the specimen collection procedure
* Patient whose physician is willing to order the genetic test
Exclusion Criteria
* Previous use of warfarin within 180 days of initiating new warfarin therapy
* Hospitalized for seven or more days before first claim for warfarin
* Previous history of genetic testing for warfarin therapy
* Known hypersensitivity to warfarin
* Patient or physician refusal to participate in the study
* Patients using warfarin residing in Olmsted County, MN
40 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Washington University School of Medicine
OTHER
Medco Health Solutions, Inc.
INDUSTRY
Responsible Party
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Medco Health Solutions, Inc.
Principal Investigators
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Robert Epstein, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Medco Health Solutions, Inc.
Locations
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Medco Health Solutions, Inc.
Franklin Lakes, New Jersey, United States
Countries
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References
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Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi: 10.1016/j.jacc.2010.03.009. Epub 2010 Apr 8.
Other Identifiers
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MedcoWarfarin1
Identifier Type: -
Identifier Source: org_study_id