Trial Outcomes & Findings for Clinical and Economic Implications of Genetic Testing for Warfarin Management (NCT NCT00964353)
NCT ID: NCT00964353
Last Updated: 2019-11-25
Results Overview
Inpatient length of stay
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
359 participants
Primary outcome timeframe
during hospital stay, up to 60 days
Results posted on
2019-11-25
Participant Flow
Patients were deleted from the study due to patient delay of surgery, baseline INR being too high, patient rescheduling or canceling surgery, no INR ordered, no admission to hospital.
Participant milestones
| Measure |
Control
Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
|
Experimental
Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
178
|
|
Overall Study
COMPLETED
|
181
|
178
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical and Economic Implications of Genetic Testing for Warfarin Management
Baseline characteristics by cohort
| Measure |
Control
n=181 Participants
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
|
Experimental
n=178 Participants
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-39 years
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Customized
40-60 years
|
55 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Age, Customized
61-75 years
|
77 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Age, Customized
75 years or more
|
30 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
171 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
341 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
181 participants
n=99 Participants
|
178 participants
n=107 Participants
|
359 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during hospital stay, up to 60 daysInpatient length of stay
Outcome measures
| Measure |
Control
n=175 Participants
Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
|
Experimental
n=170 Participants
Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
|
|---|---|---|
|
Inpatient Length of Stay
|
6.8 days
Standard Deviation 7.0
|
7.2 days
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: during hospital stay, up to 60 daysInternational Normalized Ratio
Outcome measures
| Measure |
Control
n=175 Participants
Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
|
Experimental
n=170 Participants
Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
|
|---|---|---|
|
Supratherapeutic Dosing
|
2.2 ratio
Standard Deviation 0.2
|
2.2 ratio
Standard Deviation 0.3
|
Adverse Events
Control
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Control
n=181 participants at risk
Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
|
Experimental
n=178 participants at risk
Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
|
|---|---|---|
|
Cardiac disorders
DVT or PE
|
3.9%
7/181 • Number of events 7
|
0.56%
1/178 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place