Improving Anticoagulant Therapy Through Warfarin Metabolite Profiling

NCT01964794 | Completed

• 1 other identifier: 135288
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Clinically relevant biomarkers for warfarin identified in this study will provide crucial leads for subsequent studies to assess their predictive value during anticoagulant therapy. This knowledge will aid stratifying risk among patients to improve therapeutic outcomes and decrease adverse drug events and associated health care costs. Collectively, these efforts will provide a critical foundation for future research using a metabolite biomarker strategy in a clinical setting to revolutionize warfarin therapy. Through its application, a real-time assessment of warfarin metabolism for each patient could lead to a truly personalized dosing strategy and improve patient safety for this life-saving drug.

Conditions

Stable Target INR

Keywords

Warfarin

Outcome Measures

Primary Outcomes (1)

• Metabolite Profiling

  Based on a single blood draw, identify metabolite biomarkers for achieving a stable target anticoagulant response among patients at a maintenance dose of warfarin.

  Up to 24 months

Eligibility Criteria

• Age: 60 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Originally, for this pilot study, we chose a sample population size of 150 with a focus on veterans from the Korean War. Towards the end of recruitment the protocol was revised to remove the focus on veterans from just the Korean War.

You may qualify if:

• Potential participant received a warfarin maintenance dose with a stable INR (defined as within target range over a two month (60 day) period that includes a minimum of two clinical visits).
• Potential participant has taken warfarin as prescribed over the past three days.

You may not qualify if:

• Female
• Potential participant receiving a warfarin while not achieving a stable INR (defined as within target range over a two month (60 day) period that includes a minimum of two clinical visits).
• Potential participant has not received any warfarin over the past three days.

Sponsors & Collaborators

• University of Arkansas: lead
• Central Arkansas Veterans Healthcare System: collaborator

Study Sites (2)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens to identify coumadin genetic and metabolic biomarkers.

Study Officials

• Grover P Miller, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

• Eugene Smith, III, MD

  Dentral Arkansas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 17, 2013
• Study Start: May 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

US (2)