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Hormone Replacement Therapy and Prothrombotic Variants

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ClinicalTrials.gov Identifier: NCT00049933
Recruitment Status : Completed
First Posted : November 15, 2002
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bruce Psaty, University of Washington

Brief Summary:
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.

Condition or disease
Cardiovascular Diseases Heart Diseases Cerebrovascular Accident Myocardial Infarction Hypertension

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2002
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Myocardial Infarction or Stroke [ Time Frame: Retrospective ]


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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General
Criteria
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049933


Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Bruce Psaty University of Washington

Publications:
Responsible Party: Bruce Psaty, Professor, Medicine and Epidemiology, University of Washington
ClinicalTrials.gov Identifier: NCT00049933     History of Changes
Other Study ID Numbers: 20425
5R01HL068639-04 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2002    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Stroke
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases