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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00905177
Other study ID # 700902
Secondary ID
Status Completed
Phase N/A
First received May 18, 2009
Last updated May 19, 2016
Start date June 2009
Est. completion date August 2013

Study information

Verified date May 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 687
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Hospital of the University of Pennsylvania, Anticoagulation Management Center Philadelphia Pennsylvania
United States Philadelphia Veteran Affairs Medical Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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