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

NCT00993200 | Completed Phase 4 Results DMC

• 1 other identifier: 35279
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this medicine works well, it is difficult to know how much medicine a patient needs. Many things affect how much medicine a patient needs and doses can be very different from patient to patient. It is important for patients to get the right dose to prevent clotting or bleeding problems that can happen with this medicine if the dose is too low or too high. These problems can be life-threatening. To help find the right dose, patients on warfarin must have frequent blood tests to measure how well the medicine is working. The investigators know differences in people's genes can affect how much warfarin medicine someone needs, but they don't yet know with certainty how to use this information in making patient care decisions. The hypothesis of this study is that using a patients warfarin related genetic information incorporated into a computer algorithm to be used by a warfarin provider will lead to better warfarin management compared to usual care.

Conditions

Blood Clotting

Keywords

Warfarin; Pharmacogenetic

Outcome Measures

Primary Outcomes (1)

• The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range

  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.

  variable as defined

Secondary Outcomes (2)

• Adverse Major and Minor Bleeding Events

  12 week

• Thrombotic Complication

  12 week

Study Arms (2)

Warfarin, control

ACTIVE COMPARATOR

Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.

Drug: Warfarin

Warfarin: PERMIT

EXPERIMENTAL

Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by warfarin pharmacogenetic dosing (warfarin dosing using genetic information incorporated into the PERMIT algorithm).

Genetic: warfarin pharmacogenetic dosing

Interventions

warfarin pharmacogenetic dosing GENETIC

Warfarin pharmacogenetic dosing incorporated into a validated clinical algorithm displayed in a computer (PERMIT) management interface

Warfarin: PERMIT

Warfarin DRUG

Usual care warfarin dosing

Warfarin, control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prescribed warfarin for any indication, so long as they are naïve to the drug at enrollment and are expected to receive therapy for at least 12 weeks

You may not qualify if:

• Recent cardiothoracic surgery as indication for warfarin.

Sponsors & Collaborators

• Robert Pendleton: lead
• University of Louisville: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Small sample size in this pilot trial

Results Point of Contact

• Title: Robert Pendleton
• Organization: University of Utah

robert.pendleton@hsc.utah.edu

801 581 7818

Study Officials

• Robert C Pendleton, MD

  University of Utah Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine; Director Hospitalist Program; Medical Director Thrombosis Service

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 12, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 24, 2015
• Results First Posted: May 16, 2013

Record last verified: 2015-05

Locations

US (1)