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Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
This study has been completed.
Study NCT00005515   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: July 20, 2005   History of Changes

May 25, 2000
July 20, 2005
September 1998
 
 
 
Complete list of historical versions of study NCT00005515 on ClinicalTrials.gov Archive Site
 
 
 
Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
 

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).

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.

 
Observational
Natural History
  • Cardiovascular Diseases
  • Venous Thromboembolism
  • Postmenopause
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
August 2003
 

No eligibility criteria

Female
30 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005515
 
5033
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Bruce Psaty University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP