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Predictors of Anticoagulation Control on Warfarin Therapy

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ClinicalTrials.gov Identifier: NCT00905177
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Atrial Fibrillation Deep Vein Thrombosis Heart Valve Replacement

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
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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 : June 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
A one time blood sample will be collected for specific genetic testing and vitamin K assay

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will include all self-identified Caucasians and African Americans initiating warfarin therapy.
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905177


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania, Anticoagulation Management Center
Philadelphia, Pennsylvania, United States, 19104
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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00905177     History of Changes
Other Study ID Numbers: 700902
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by University of Pennsylvania:
Atrial Fibrillation
deep vein thrombosis
anticoagulation
warfarin
coumadin

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Warfarin
Anticoagulants