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This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.
Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician dosing of warfarin | Experimental | Warfarin dose based on clinician dosing without the use of warfarin pharmacogenetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin Dose based on pharmacogenetics | Genetic | Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm |
| Measure | Description | Time Frame |
|---|---|---|
| In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). | Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk). | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J. Destache, Pharm. D. | Creighton University | Principal Investigator |
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Subjects will be recruited from the warfarin clinic at the Creighton Cardiac Center from 7/06-6/07.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacist Dosing | Warfarin dose based on pharmacist dosing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacist Dosing | Warfarin dose based on pharmacist dosing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). | Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk). | power analysis based on data from Sconce, et al. | Posted | Mean | Standard Deviation | mg/wk | six months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacist Dosing | Warfarin dose based on pharmacist dosing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Destache | Creighton University | 402-280-4744 | destache@creighton.edu |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Age Continuous | Age greater than 40 years | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline INR | Mean | Standard Deviation | ratio |
|
| warfarin dose | Mean | Standard Deviation | mg/wk |
|
| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 102 |
| 0 |
| 102 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D013927 | Thrombosis |