Predictors of Anticoagulation Control on Warfarin Therapy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by University of Pennsylvania.
Recruitment status was Recruiting

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin sodium

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

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

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:


Atrial Fibrillation Venous Thrombosis Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis	Heart Diseases Pathologic Processes Thrombosis Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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