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Predictors of Anticoagulation Control on Warfarin Therapy

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00905177
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
687
Enrollment
2
Locations
50
Duration (Months)
343.5
Patients Per Site
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective cohort study among adult patients requiring warfarin therapy. Patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. We will then develop a dosing equation for warfarin using patient, environmental and genetic factors.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    687 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predictors of Anticoagulation Control on Warfarin Therapy
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Aug 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • All Caucasians and African Americans who are new to warfarin therapy
      Exclusion Criteria:

      • Under 21 years of age

      • Non caucasian

      • Non african american

      • Have an abnormal INR before warfarin or heparin therapy

      • Unable to provide consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hospital of the University of Pennsylvania, Anticoagulation Management Center Philadelphia Pennsylvania United States 19104
      2 Philadelphia Veteran Affairs Medical Center Philadelphia Pennsylvania United States 19104

      Sponsors and Collaborators

      • University of Pennsylvania
      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      • Principal Investigator: Stephen E. Kimmel, M.D. MS, University of Pennsylvania

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Pennsylvania
      ClinicalTrials.gov Identifier:
      NCT00905177
      Other Study ID Numbers:
      • 700902
      First Posted:
      May 20, 2009
      Last Update Posted:
      May 20, 2016
      Last Verified:
      May 1, 2016
      Keywords provided by University of Pennsylvania
      Atrial Fibrillation
      deep vein thrombosis
      anticoagulation
      warfarin
      coumadin
      Additional relevant MeSH terms:
      Atrial Fibrillation
      Thrombosis
      Venous Thrombosis

      Study Results

      No Results Posted as of May 20, 2016