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Home > "M" Clinical Trials Conditions > Mutations, Hormone Therapy (HRT) and Venous Thromboembolism  Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
For Condition: Postmenopause,Cardiovascular Diseases,Venous Thromboembolism
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To assess the interaction between hormone replacement therapy and the prothrombotic mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the incidence of venous thromboembolism (VTE) in a population-based case-control study conducted at Group Health Cooperative of Puget Sound (GHC).
Details: BACKGROUND: Epidemiologic studies have identified Factor V Leiden as the most common cause of heritable thrombophilia, a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of venous thromboembolism (VTE). In pre-menopausal women, the use of oral contraceptives is associated with a 4-fold increase in VTE risk, and the joint effects of oral contraceptive use and Factor V Leiden carriership increase the VTE risk of by a factor of 35. Recently, the results of several observational studies and randomized clinical trials suggest that in post-menopausal women, the use of hormone replacement therapy is associated with a 3-fold increase in VTE risk. Whether post-menopausal women with prothrombotic mutations experience a similar 20-fold increase in risk when they take post-menopausal hormones remains unknown. DESIGN NARRATIVE: In this case-control study, post-menopausal women with a first episode of objectively confirmed venous thromboembolism, and population-based controls were identified and recruited from the GHC enrollment files. Controls were frequency matched to the cases on age and calendar-year. Data collection included a review of ambulatory medical record and a telephone interview. The GHC computerized pharmacy database was used to assess exposure to hormone replacement therapy. A venous blood specimen was obtained from consenting subjects, processed into aliquots of white cells, plasma, and red cells, and stored at 70 degrees C prior to laboratory analysis. DNA was extracted from white cells, and molecular genotyping assays were conducted to assess carriership of prothrombotic mutations.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrucePsaty, , University of Washington
Additional Information:
Study ID Numbers: 5033;
Study Start Date: September 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005515
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Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
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