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Hormone Replacement Therapy and Prothrombotic Variants

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00049933
First received: November 14, 2002
Last updated: December 18, 2012
Last verified: December 2012

November 14, 2002
December 18, 2012
September 2002
August 2008   (final data collection date for primary outcome measure)
Myocardial Infarction or Stroke [ Time Frame: Retrospective ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00049933 on ClinicalTrials.gov Archive Site
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Hormone Replacement Therapy and Prothrombotic Variants
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To examine in postmenopausal women the potential interactions of hormone replacement therapy with other blood clotting factors on the risk of cardiovascular diseases such as heart attack or stroke.

BACKGROUND:

Estrogens are prothrombotic. Recently, the Heart and Estrogen/progestin Replacement Study (HERS), renewed interest in the adverse effects of hormone replacement therapy (HRT). In HERS, HRT was no better than placebo at preventing coronary events. In post hoc analyses, treatment was associated with early harm and late benefit. In an American Heart Association funded case-control study, a potential interaction was observed between HRT and the prothrombin G20210A variant on the risk of first myocardial infarction (MI) in post-menopausal women with hypertension.

DESIGN NARRATIVE:

The study has a case-control design. The Group Health Cooperative (GHC) computerized files will be used to identify postmenopausal women, aged 30 to 79 yrs, with incident myocardial infarction (MI) or stroke during 1/2000-12/2004. Population-based controls, sampled from the GHC enrollment files, will be frequency matched to cases by age, calendar year, and treated hypertension. Data collection will include medical-record review, telephone interview of consenting subjects, and venous-blood collection. Standard methods will be used to assay variant alleles. The GHC computerized pharmacy records will serve as the primary source of information about the use of HRT. Data analysis will involve restriction, stratification, and logistic regression. Case-control and case-only analyses are planned. There will be a total of 600 MI cases, 420 stroke cases and 1800 controls.

The primary purpose is to examine the potential interactions of hormone replacement therapy with other procoagulant variants on the risk of cardiovascular events. The main variants of interest are: (la) factor XIIIA Val34Leu; (ib) platelet glycoprotein (PGP) Jib Ile843Ser; (ic) PGP IIIa Leu33Pro; and (id) PGP Ia C807T. The secondary aims include the assessment of other drug-gene, risk-factor-gene or gene-gene interactions on risk: (2a) the interaction between PGP IIb Ser843, PGP lila Leu33Pro and PGP Ia C807T and traditional cardiovascular risk factors such as smoking and obesity on the risk of MI and stroke; (2b) the interaction between three coagulation factor XIII polymorphisms and PAl-1 4G/5G on the risk of stroke in women; and (2c) the interaction between aspirin use and glycoprotein IIIa Leu33Pro on the risk of MI and stroke.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

General

  • Cardiovascular Diseases
  • Heart Diseases
  • Cerebrovascular Accident
  • Myocardial Infarction
  • Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
August 2008
August 2008   (final data collection date for primary outcome measure)

No eligibility criteria

Female
30 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00049933
1193, 5R01HL068639-04
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University of Washington
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Bruce Psaty University of Washington
University of Washington
December 2012

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