Cardiovascular DiseasesNCT00005515
Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
An observational study of Cardiovascular Diseases and Venous Thromboembolism, run by University of Washington.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 89 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Venous Thromboembolism, Postmenopause
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1998to Aug 2003
- 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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
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).
Read the detailed description
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.
- Medical subject headings
- Cardiovascular Diseases, Venous Thromboembolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1998
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Bruce Psaty, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005515
- Sponsor's protocol ID
- 5033
- Other IDs
- R01HL060739
- Status last verified
- Jul 2005
- First submitted
- 25 May 2000
- Last updated
- 10 Feb 2016
- Results posted
- No
Publications
Psaty BM, Smith NL, Lemaitre RN, Vos HL, Heckbert SR, LaCroix AZ, Rosendaal FR. Hormone replacement therapy, prothrombotic mutations, and the risk of incident nonfatal myocardial infarction in postmenopausal women. JAMA. 2001 Feb 21;285(7):906-13. doi: 10.1001/jama.285.7.906.
PubMed 11180734Klungel OH, Heckbert SR, Longstreth WT Jr, Furberg CD, Kaplan RC, Smith NL, Lemaitre RN, Leufkens HG, de Boer A, Psaty BM. Antihypertensive drug therapies and the risk of ischemic stroke. Arch Intern Med. 2001 Jan 8;161(1):37-43. doi: 10.1001/archinte.161.1.37.
PubMed 11146696Psaty BM, Furberg CD, Pahor M, Alderman M, Kuller LH. National guidelines, clinical trials, and quality of evidence. Arch Intern Med. 2000 Sep 25;160(17):2577-80. doi: 10.1001/archinte.160.17.2577. No abstract available.
PubMed 10999970Psaty BM, Smith NL, Heckbert SR, Vos HL, Lemaitre RN, Reiner AP, Siscovick DS, Bis J, Lumley T, Longstreth WT Jr, Rosendaal FR. Diuretic therapy, the alpha-adducin gene variant, and the risk of myocardial infarction or stroke in persons with treated hypertension. JAMA. 2002 Apr 3;287(13):1680-9. doi: 10.1001/jama.287.13.1680.
PubMed 11926892Psaty BM, Doggen C, Vos HL, Vandenbroucke JP, Rosendaal FR. Association of the alpha-adducin polymorphism with blood pressure and risk of myocardial infarction. J Hum Hypertens. 2000 Feb;14(2):95-7. doi: 10.1038/sj.jhh.1000943.
PubMed 10723114Psaty BM, Rennie D. Stopping medical research to save money: a broken pact with researchers and patients. JAMA. 2003 Apr 23-30;289(16):2128-31. doi: 10.1001/jama.289.16.2128. No abstract available.
PubMed 12709471Reiner AP, Heckbert SR, Vos HL, Ariens RA, Lemaitre RN, Smith NL, Lumley T, Rea TD, Hindorff LA, Schellenbaum GD, Rosendaal FR, Siscovick DS, Psaty BM. Genetic variants of coagulation factor XIII, postmenopausal estrogen therapy, and risk of nonfatal myocardial infarction. Blood. 2003 Jul 1;102(1):25-30. doi: 10.1182/blood-2002-07-2308. Epub 2002 Nov 27.
PubMed 12456499Bis JC, Smith NL, Psaty BM, Heckbert SR, Edwards KL, Lemaitre RN, Lumley T, Rosendaal FR. Angiotensinogen Met235Thr polymorphism, angiotensin-converting enzyme inhibitor therapy, and the risk of nonfatal stroke or myocardial infarction in hypertensive patients. Am J Hypertens. 2003 Dec;16(12):1011-7. doi: 10.1016/j.amjhyper.2003.07.018.
PubMed 14643574Doggen CJ, Lemaitre RN, Smith NL, Heckbert SR, Psaty BM. HMG CoA reductase inhibitors and the risk of venous thrombosis among postmenopausal women. J Thromb Haemost. 2004 May;2(5):700-1. doi: 10.1111/j.1538-7836.2004.00696.x. No abstract available.
PubMed 15099273Smith 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 15557504
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT00005515
- Acronym / sponsor ID
- 5033
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1998
- Study completion
- Aug 2003
- First posted
- 26 May 2000 (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 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).
Detailed description
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.
Study design
Who may qualify
- Ages
- 30 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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
Not reported in the source record.
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 10 Feb 2016.
- Background: PubMed 11180734Psaty BM, Smith NL, Lemaitre RN, Vos HL, Heckbert SR, LaCroix AZ, Rosendaal FR. Hormone replacement therapy, prothrombotic mutations, and the risk of incident nonfatal myocardial infarction in postmenopausal women. JAMA. 2001 Feb 21;285(7):906-13. doi: 10.1001/jama.285.7.906.
- Background: PubMed 11146696Klungel OH, Heckbert SR, Longstreth WT Jr, Furberg CD, Kaplan RC, Smith NL, Lemaitre RN, Leufkens HG, de Boer A, Psaty BM. Antihypertensive drug therapies and the risk of ischemic stroke. Arch Intern Med. 2001 Jan 8;161(1):37-43. doi: 10.1001/archinte.161.1.37.
- Background: PubMed 10999970Psaty BM, Furberg CD, Pahor M, Alderman M, Kuller LH. National guidelines, clinical trials, and quality of evidence. Arch Intern Med. 2000 Sep 25;160(17):2577-80. doi: 10.1001/archinte.160.17.2577. No abstract available.
- Background: PubMed 11926892Psaty BM, Smith NL, Heckbert SR, Vos HL, Lemaitre RN, Reiner AP, Siscovick DS, Bis J, Lumley T, Longstreth WT Jr, Rosendaal FR. Diuretic therapy, the alpha-adducin gene variant, and the risk of myocardial infarction or stroke in persons with treated hypertension. JAMA. 2002 Apr 3;287(13):1680-9. doi: 10.1001/jama.287.13.1680.
- Background: PubMed 10723114Psaty BM, Doggen C, Vos HL, Vandenbroucke JP, Rosendaal FR. Association of the alpha-adducin polymorphism with blood pressure and risk of myocardial infarction. J Hum Hypertens. 2000 Feb;14(2):95-7. doi: 10.1038/sj.jhh.1000943.
- Background: PubMed 12709471Psaty BM, Rennie D. Stopping medical research to save money: a broken pact with researchers and patients. JAMA. 2003 Apr 23-30;289(16):2128-31. doi: 10.1001/jama.289.16.2128. No abstract available.
- Background: PubMed 12456499Reiner AP, Heckbert SR, Vos HL, Ariens RA, Lemaitre RN, Smith NL, Lumley T, Rea TD, Hindorff LA, Schellenbaum GD, Rosendaal FR, Siscovick DS, Psaty BM. Genetic variants of coagulation factor XIII, postmenopausal estrogen therapy, and risk of nonfatal myocardial infarction. Blood. 2003 Jul 1;102(1):25-30. doi: 10.1182/blood-2002-07-2308. Epub 2002 Nov 27.
- Background: PubMed 14643574Bis JC, Smith NL, Psaty BM, Heckbert SR, Edwards KL, Lemaitre RN, Lumley T, Rosendaal FR. Angiotensinogen Met235Thr polymorphism, angiotensin-converting enzyme inhibitor therapy, and the risk of nonfatal stroke or myocardial infarction in hypertensive patients. Am J Hypertens. 2003 Dec;16(12):1011-7. doi: 10.1016/j.amjhyper.2003.07.018.
- Background: PubMed 15099273Doggen CJ, Lemaitre RN, Smith NL, Heckbert SR, Psaty BM. HMG CoA reductase inhibitors and the risk of venous thrombosis among postmenopausal women. J Thromb Haemost. 2004 May;2(5):700-1. doi: 10.1111/j.1538-7836.2004.00696.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.
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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
University of Washington
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Venous Thromboembolism, 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 10 Feb 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005515, which also lists 11 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 10 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.