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

This study has been completed.

Sponsor:

Collaborator:

University of Louisville

Information provided by (Responsible Party):

Robert Pendleton, University of Utah

ClinicalTrials.gov Identifier:

NCT00993200

First received: October 8, 2009

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Results First Received: August 13, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Blood Clotting
Interventions:	Genetic: warfarin pharmacogenetic dosing Drug: Warfarin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty six subjects were enrolled and randomized

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Naive to warfarin were randomized to groups

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Warfarin, Control	Warfarin: PERMIT
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Warfarin, Control	Warfarin: PERMIT	Total
Number of Participants [units: participants]	13	13	26
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	5	11
>=65 years	7	8	15
Age [units: years] Mean ± Standard Deviation	45 ± 10	59 ± 10	52 ± 10
Gender [units: participants]
Female	6	6	12
Male	7	7	14
Region of Enrollment [units: participants]
United States	13	13	26

Outcome Measures

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1. Primary:

The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range [ Time Frame: variable as defined ]

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2. Secondary:

Adverse Major and Minor Bleeding Events [ Time Frame: 12 week ]

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3. Secondary:

Thrombotic Complication [ Time Frame: 12 week ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size in this pilot trial

Results Point of Contact:

Name/Title: Robert Pendleton
Organization: University of Utah
phone: 801 581 7818
e-mail: robert.pendleton@hsc.utah.edu

No publications provided

Responsible Party:	Robert Pendleton, University of Utah
ClinicalTrials.gov Identifier:	NCT00993200 History of Changes
Other Study ID Numbers:	35279
Study First Received:	October 8, 2009
Results First Received:	August 13, 2012
Last Updated:	April 8, 2013
Health Authority:	United States: Institutional Review Board

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