Trial Outcomes & Findings for Personalized Medicine Interface Tool (PerMIT): Warfarin: A Trial Comparing Usual Care Warfarin Initiation to PerMIT Pharmacogenetic Guided Warfarin Therapy (NCT NCT00993200)

Results Overview

The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

variable as defined

Results posted on

2015-06-24

Participant Flow

Twenty six subjects were enrolled and randomized

Naive to warfarin were randomized to groups

Participant milestones

Participant milestones
Measure	Warfarin, Control Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.	Warfarin: PERMIT Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personalized Medicine Interface Tool (PerMIT): Warfarin: A Trial Comparing Usual Care Warfarin Initiation to PerMIT Pharmacogenetic Guided Warfarin Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Warfarin, Control n=13 Participants Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.	Warfarin: PERMIT n=13 Participants Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 10 • n=5 Participants	59 years STANDARD_DEVIATION 10 • n=7 Participants	52 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: variable as defined

Population: analysis per protocol

The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.

Outcome measures

Outcome measures
Measure	Standard n=13 Participants Standard of care warfarin management	PERMIT n=13 Participants Warfarin management with use of gene-based warfarin dosing algorithm
The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range	8.3 days Standard Deviation 2	4.7 days Standard Deviation 2

SECONDARY outcome

Timeframe: 12 week

Number of major and minor bleeding events

Outcome measures

Outcome measures
Measure	Standard n=13 Participants Standard of care warfarin management	PERMIT n=13 Participants Warfarin management with use of gene-based warfarin dosing algorithm
Adverse Major and Minor Bleeding Events	0 number of bleeding events	0 number of bleeding events

SECONDARY outcome

Timeframe: 12 week

Number of thrombotic events

Outcome measures

Outcome measures
Measure	Standard n=13 Participants Standard of care warfarin management	PERMIT n=13 Participants Warfarin management with use of gene-based warfarin dosing algorithm
Thrombotic Complication	0 number of thrombotic events	0 number of thrombotic events

Adverse Events

Warfarin, Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin: PERMIT

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

Robert Pendleton

University of Utah

Phone: 801 581 7818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place