Trial Outcomes & Findings for Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm (NCT NCT00511173)
NCT ID: NCT00511173
Last Updated: 2012-12-11
Results Overview
Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
six months
Results posted on
2012-12-11
Participant Flow
Subjects will be recruited from the warfarin clinic at the Creighton Cardiac Center from 7/06-6/07.
Participant milestones
| Measure |
Pharmacist Dosing
Warfarin dose based on pharmacist dosing
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
Baseline characteristics by cohort
| Measure |
Pharmacist Dosing
n=102 Participants
Warfarin dose based on pharmacist dosing
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
|
Age Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
|
Baseline INR
|
2.6 ratio
STANDARD_DEVIATION .4 • n=5 Participants
|
|
warfarin dose
|
35.4 mg/wk
STANDARD_DEVIATION 16.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: power analysis based on data from Sconce, et al.
Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).
Outcome measures
| Measure |
Algorithm Dosing
n=102 Participants
Warfarin dose based on algorithm by Sconce, et al.
|
Pharmacist Dosing
n=102 Participants
Warfarin dose based on clinician dosing
|
|---|---|---|
|
In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).
|
46.9 mg/wk
Standard Deviation 7.5
|
35.4 mg/wk
Standard Deviation 16.4
|
Adverse Events
Pharmacist Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place