N/A
N=70
Warfarin and Coronary Calcification Project
Coronary Calcification
Bottom Line
View on ClinicalTrials.gov: NCT00868712 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: 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 — 175; 289; 426 Agatston Score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Walter Reed Army Medical Center
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
175; 289; 426 | — |
| SECONDARY International Normalized Ratio |
1.8; 2.4; 2.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00868712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.