Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049933
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2002-11-14
Brief Title:
Hormone Replacement Therapy and Prothrombotic Variants
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
BACKGROUND
Estrogens are prothrombotic Recently the Heart and Estrogenprogestin 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 12000-122004 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 4G5G 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
Estrogens are prothrombotic Recently the Heart and Estrogenprogestin 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 12000-122004 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 4G5G 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL068639-04 | NIH | None | httpsreporternihgovquickSearch5R01HL068639-04 |