Cardiovascular DiseasesNCT00049933
Hormone Replacement Therapy and Prothrombotic Variants
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: General
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Stroke, Myocardial Infarction, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Infarction or Stroke
Measured: Retrospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2002 (estimated)
- Study startSep 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bruce Psaty, University of Washington
- Investigators
- Bruce Psaty, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049933
- Sponsor's protocol ID
- 20425
- Other IDs
- 5R01HL068639-04
- Status last verified
- May 2018
- First submitted
- 14 Nov 2002
- Last updated
- 7 May 2018
- Results posted
- No
Publications
Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH, Weiss NS. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA. 2003 May 21;289(19):2534-44. doi: 10.1001/jama.289.19.2534.
PubMed 12759325Rhoads CS, Psaty BM, Olson JL, Furberg CD. Medications and cardiovascular health in older adults: room for improvement in prevention and treatment. Am J Geriatr Cardiol. 2004 May-Jun;13(3):161-7. doi: 10.1111/j.1076-7460.2004.02124.x. No abstract available.
PubMed 15133419Smith NL, Heckbert SR, Lemaitre RN, Reiner AP, Lumley T, Weiss NS, Larson EB, Rosendaal FR, Psaty BM. Esterified estrogens and conjugated equine estrogens and the risk of venous thrombosis. JAMA. 2004 Oct 6;292(13):1581-7. doi: 10.1001/jama.292.13.1581.
PubMed 15467060Tirschwell DL, Smith NL, Heckbert SR, Lemaitre RN, Longstreth WT Jr, Psaty BM. Association of cholesterol with stroke risk varies in stroke subtypes and patient subgroups. Neurology. 2004 Nov 23;63(10):1868-75. doi: 10.1212/01.wnl.0000144282.42222.da.
PubMed 15557504Altorki N, Wang X, Damman B, Jones DR, Wigle D, Port J, Conti M, Ashrafi AS, Liberman M, Landreneau R, Yasufuku K, Yang S, Mitchell JD, Keenan R, Bauer T, Miller D, Kozono D, Mentlick J, Vokes E, Stinchcombe TE. Recurrence of Non-Small Cell Lung Cancer With Visceral Pleural Invasion: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2024 Sep 1;10(9):1179-1186. doi: 10.1001/jamaoncol.2024.2491.
PubMed 39088196
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Replacement Therapy and Prothrombotic Variants
- ClinicalTrials.gov ID
- NCT00049933
- Acronym / sponsor ID
- 20425
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial Infarction or Stroke
Time frame: Retrospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 12759325Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH, Weiss NS. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA. 2003 May 21;289(19):2534-44. doi: 10.1001/jama.289.19.2534.
- Background: PubMed 15133419Rhoads CS, Psaty BM, Olson JL, Furberg CD. Medications and cardiovascular health in older adults: room for improvement in prevention and treatment. Am J Geriatr Cardiol. 2004 May-Jun;13(3):161-7. doi: 10.1111/j.1076-7460.2004.02124.x. No abstract available.
- Background: PubMed 15467060Smith NL, Heckbert SR, Lemaitre RN, Reiner AP, Lumley T, Weiss NS, Larson EB, Rosendaal FR, Psaty BM. Esterified estrogens and conjugated equine estrogens and the risk of venous thrombosis. JAMA. 2004 Oct 6;292(13):1581-7. doi: 10.1001/jama.292.13.1581.
- Background: PubMed 15557504Tirschwell DL, Smith NL, Heckbert SR, Lemaitre RN, Longstreth WT Jr, Psaty BM. Association of cholesterol with stroke risk varies in stroke subtypes and patient subgroups. Neurology. 2004 Nov 23;63(10):1868-75. doi: 10.1212/01.wnl.0000144282.42222.da.
- Derived from this study: PubMed 39088196Altorki N, Wang X, Damman B, Jones DR, Wigle D, Port J, Conti M, Ashrafi AS, Liberman M, Landreneau R, Yasufuku K, Yang S, Mitchell JD, Keenan R, Bauer T, Miller D, Kozono D, Mentlick J, Vokes E, Stinchcombe TE. Recurrence of Non-Small Cell Lung Cancer With Visceral Pleural Invasion: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2024 Sep 1;10(9):1179-1186. doi: 10.1001/jamaoncol.2024.2491.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Psaty study chair
University of Washington
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Infarction or Stroke (time frame: Retrospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00049933, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.