Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism
Conditions
Keywords
mechanical valve
Brief summary
This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.
Detailed description
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.
Interventions
GENETICWarfarin Dose based on pharmacogenetics
Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy
Exclusion criteria
* Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). | six months | Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk). |
Participant flow
Recruitment details
Subjects will be recruited from the warfarin clinic at the Creighton Cardiac Center from 7/06-6/07.
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist Dosing Warfarin dose based on pharmacist dosing | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Pharmacist Dosing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 36 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants |
| Age Continuous | 70 years |
| Baseline INR | 2.6 ratio STANDARD_DEVIATION 0.4 |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 56 Participants |
| warfarin dose | 35.4 mg/wk STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
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).
Time frame: six months
Population: power analysis based on data from Sconce, et al.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Algorithm Dosing | In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). | 46.9 mg/wk | Standard Deviation 7.5 |
| Pharmacist Dosing | In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). | 35.4 mg/wk | Standard Deviation 16.4 |
Comparison: Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in \> 100 patients enrolled into each group.p-value: <0.05t-test, 2 sided