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
Sex: Female, Male Female	111 Participants n=5 Participants	93 Participants n=7 Participants	204 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	85 Participants n=7 Participants	155 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	171 Participants n=5 Participants	170 Participants n=7 Participants	341 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	84 Participants n=5 Participants	72 Participants n=7 Participants	156 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	93 Participants n=7 Participants	178 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	181 participants n=5 Participants	178 participants n=7 Participants	359 participants n=5 Participants
Age, Customized 18-39 years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Customized 40-60 years	55 Participants n=5 Participants	75 Participants n=7 Participants	130 Participants n=5 Participants
Age, Customized 61-75 years	77 Participants n=5 Participants	60 Participants n=7 Participants	137 Participants n=5 Participants
Age, Customized 75 years or more	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: during hospital stay, up to 60 days

Inpatient 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 days

International 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

Dr David Meltzer

University of Chicago

Phone: 773-702-0836

Email: dmeltzer@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place