NCT00905177

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
687

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

May 18, 2009

Last Update Submit

May 19, 2016

Conditions

Atrial FibrillationDeep Vein ThrombosisHeart Valve Replacement

Keywords

Atrial Fibrillationdeep vein thrombosisanticoagulationwarfarincoumadin

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will include all self-identified Caucasians and African Americans initiating warfarin therapy.

You may qualify if:

  • All Caucasians and African Americans who are new to warfarin therapy

You may not qualify if:

  • Under 21 years of age
  • Non caucasian
  • Non african american
  • Have an abnormal INR before warfarin or heparin therapy
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania, Anticoagulation Management Center

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia Veteran Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A one time blood sample will be collected for specific genetic testing and vitamin K assay

MeSH Terms

Conditions

Atrial FibrillationVenous Thrombosis

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular Diseases

Study Officials

  • Stephen E. Kimmel, M.D. MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

US(2)