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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
History of Changes
  Purpose
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
Atrial Fibrillation
Deep Vein Thrombosis
Heart Valve Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Anticoagulation Control on Warfarin Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

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

Enrollment: 687
Study Start Date: June 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility
Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00905177     History of Changes
Other Study ID Numbers: 700902 
Study First Received: May 18, 2009
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 29, 2016