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Trial record 75 of 156 for:    warfarin AND Vitamin K

Warfarin and Coronary Calcification Project (WACC)

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ClinicalTrials.gov Identifier: NCT00868712
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : August 24, 2012
Last Update Posted : August 24, 2012
Sponsor:
Information provided by (Responsible Party):
Todd C. Villines, Walter Reed Army Medical Center

Tracking Information
First Submitted Date March 24, 2009
First Posted Date March 25, 2009
Results First Submitted Date February 2, 2010
Results First Posted Date August 24, 2012
Last Update Posted Date August 24, 2012
Study Start Date May 2004
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2012)
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. ]
The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; >1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.
Original Primary Outcome Measures
 (submitted: March 24, 2009)
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. ]
Change History Complete list of historical versions of study NCT00868712 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 23, 2012)
International Normalized Ratio [ 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. ]
The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.
Original Secondary Outcome Measures
 (submitted: March 24, 2009)
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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Warfarin and Coronary Calcification Project
Official Title Warfarin and Coronary Calcification Project
Brief Summary 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 computed tomography (CT) scan (electron-beam CT) and assessing to see if the amount is influenced by the amount of time a patient has been taking warfarin. The researchers will exclude patients with known coronary artery disease, chronic kidney disease or hyperparathyroidism.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Coronary Calcification
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Warfarin use < 6 months
  • 2
    Warfarin use 6-24 months
  • 3
    Warfarin use >24 months
Publications * Villines TC, O'Malley PG, Feuerstein IM, Thomas S, Taylor AJ. Does prolonged warfarin exposure potentiate coronary calcification in humans? Results of the warfarin and coronary calcification study. Calcif Tissue Int. 2009 Dec;85(6):494-500. doi: 10.1007/s00223-009-9300-4. Epub 2009 Oct 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2012)
70
Original Estimated Enrollment
 (submitted: March 24, 2009)
100
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 18 years of age or older
  • 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 glomerular filtration rate (GFR)<30
  • History of hyperparathyroidism
  • Current hypercalcemia
  • Current hyperphosphatemia
  • Uncertain duration of warfarin therapy
  • Lack of records documenting international normalized ratio (INR) during therapy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00868712
Other Study ID Numbers WU# 04-12020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Todd C. Villines, Walter Reed Army Medical Center
Study Sponsor Walter Reed Army Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Walter Reed Army Medical Center
Verification Date August 2012