Warfarin and Coronary Calcification Project - Full Text View

Sponsored by:	Walter Reed Army Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00868712

Purpose

The purpose of the study is to assess whether the use of warfarin, a commonly used anticoagulation drug, is associated with increased amounts of coronary artery calcification. Studies in animals and preliminary but small retrospective studies in humans have suggested a possible link to increased tissue calcification with use of this drug. The researchers will investigate this by assessing the amount of calcification seen in the coronary arteries using a specialized CT scan (electron-beam CT) and assessing to see if the amount is influenced by the amount of time a patient has been taking coumadin (warfarin). The researchers will exclude patients with known coronary artery disease, chronic kidney disease or hyperparathyroidism.

Condition
Coronary Calcification

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Warfarin and Coronary Calcification Project

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

Coronary calcification (presence and degree as measured by Agatston score) attributed to duration of warfarin use in months after controlling for standard cardiovascular risk factors to include the Framingham risk score [ Time Frame: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevalence and severity of coronary calcification related to intensity of anticoagulation, measured as the mean INR during treatment multiplied by the duration of warfarin use [ Time Frame: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	May 2004
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Warfarin use < 6 months
2 Warfarin use 6-24 months
3 Warfarin use >24 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients without known coronary heart disease, disorders of calcium metabolism or chronic kidney disease aged > 18 years who are referred to take or currently taking warfarin and are followed in the Anticoagulation Management Clinic at Walter Reed Army Medical Center (WRAMC).

Criteria

Inclusion Criteria:

Age >18 years of age
Patients referred to begin or already treated with warfarin anticoagulation therapy.

Exclusion Criteria:

Known prior myocardial infarction or coronary heart disease
History of advanced chronic kidney disease manifested by serum creatinine>2 or calculated GFR<30
History of hyperparathyroidism
Current hypercalcemia
Current hyperphosphatemia
Uncertain duration of warfarin therapy
Lack of records documenting INR during therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868712

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed Army Medical Center

More Information

No publications provided

Responsible Party:	Cardiology Service, Walter Reed Army Medical Center ( Todd C. Villines, MD )
Study ID Numbers:	WU# 04-12020
Study First Received:	March 24, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00868712 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

coronary calcification
vitamin K dependent proteins
warfarin

Study placed in the following topic categories:

Calcinosis
Anticoagulants
Metabolic Diseases
Vitamins

Vitamin K
Warfarin
Metabolic Disorder

Additional relevant MeSH terms:

Calcium Metabolism Disorders
Calcinosis
Anticoagulants
Metabolic Diseases

Therapeutic Uses
Hematologic Agents
Warfarin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009