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Predictors of Anticoagulation Control on Warfarin Therapy

This study is currently recruiting participants.
Verified December 2009 by University of Pennsylvania
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00905177
First received: May 18, 2009
Last updated: December 1, 2009
Last verified: December 2009
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


Estimated Enrollment: 1119
Study Start Date: June 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905177

Contacts
Contact: Luanne Bershaw, LPN,BA,CIP 215-573-9242 lbershaw@mail.med.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania, Anticoagulation Management Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Luanne Bershaw, LPN,BA,CIP     215-573-9242     lbershaw@mail.med.upenn.edu    
Contact: Stephen E. Kimmel, M.D.     215-898-1740     stevek@mail.med.upenn.edu    
Principal Investigator: Stephen E. Kimmel, MD., MSCE.            
Philadelphia Veteran Affairs Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Luanne Bershaw, LPN,BA,CIP     215-573-9242     lbershaw@mail.med.upenn.edu    
Principal Investigator: Stephen E. Kimmel, M.D.            
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

No publications provided

Responsible Party: Steve Kimmel, M.D., MSce, University of Pennsylvania, School of Medicine
ClinicalTrials.gov Identifier: NCT00905177     History of Changes
Other Study ID Numbers: 700902
Study First Received: May 18, 2009
Last Updated: December 1, 2009
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:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013