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Predictors of Anticoagulation Control on Warfarin Therapy

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00905177
First received: May 18, 2009
Last updated: May 19, 2016
Last verified: May 2016
May 18, 2009
May 19, 2016
June 2009
August 2013   (Final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT00905177 on ClinicalTrials.gov Archive Site
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Predictors of Anticoagulation Control on Warfarin Therapy
Predictors of Anticoagulation Control on Warfarin Therapy
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
A one time blood sample will be collected for specific genetic testing and vitamin K assay
Non-Probability Sample
Study population will include all self-identified Caucasians and African Americans initiating warfarin therapy.
  • Atrial Fibrillation
  • Deep Vein Thrombosis
  • Heart Valve Replacement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
687
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00905177
700902
No
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephen E. Kimmel, M.D. MS University of Pennsylvania
University of Pennsylvania
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP