Heart DiseasePhase 3ERANCT03097120
The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.
A Phase 3 study testing 0.625 mg of conjugated equine estrogen and 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate in people with Heart Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Heart Disease
- What is being tested?
- 0.625 mg of conjugated equine estrogen and 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1995to Jan 2001
- Phase
- Phase 3
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal
- not currently receiving estrogen-replacement treatment
- one or more epicardial coronary stenoses of at least 30 percent of the luminal diameter, as measured by quantitative coronary angiography
Who cannot join
- known or suspected breast or endometrial carcinoma
- previous or planned coronary-artery bypass surgery,
- a history of deep-vein thrombosis or pulmonary embolism,
- symptomatic gallstones,
- serum aspartate aminotransferase level more than 1.5 times the normal value,
- fasting triglyceride level of more than 400 mg per deciliter
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- serum creatinine level of more than 2.0 mg per deciliter
- more than 70 percent stenosis of the left main coronary artery,
- uncontrolled hypertension, or
- uncontrolled diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: The Estrogen Replacement and Atherosclerosis Trial
Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects.
Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.
- Conditions
- Heart Disease
- Being tested
- 0.625 mg of conjugated equine estrogen, 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate, placebo tablets
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.625 mg of conjugated equine estrogenDrug
one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily
0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetateDrug
one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily
placebo tabletsDrug
two placebo tablets daily
| Study group | Role | What they receive |
|---|---|---|
| unopposed estrogen | Active comparator | 0.625 mg of conjugated equine estrogen Receives: Drug: 0.625 mg of conjugated equine estrogen |
| estrogen-plus-medroxyprogesterone | Active comparator | 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate Receives: Drug: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate |
| placebo | Placebo comparator | placebo Receives: Drug: placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean minimal coronary-artery diameter
mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis
Measured: at average of 3.2 years follow-up
Secondary outcomes (3)
stenosis as a percentage of the reference diameter
Measured: at average of 3.2 years follow-up
development of new lesions in a patient
Measured: at average of 3.2 years follow-up
Models focusing on change in diameter were also examined
Measured: at average of 3.2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJan 1995
- Primary completionJan 2001
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David M. Herrington, MD, MHS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097120
- Sponsor's protocol ID
- U01HL45488
- Acronym
- ERA
- Status last verified
- Jul 2018
- First submitted
- 26 Apr 2011
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Herrington DM, Reboussin DM, Klein KP, Sharp PC, Shumaker SA, Snyder TE, Geisinger KR. The estrogen replacement and atherosclerosis (ERA) study: study design and baseline characteristics of the cohort. Control Clin Trials. 2000 Jun;21(3):257-85. doi: 10.1016/s0197-2456(00)00054-4.
PubMed 10822123Herrington DM, Reboussin DM, Brosnihan KB, Sharp PC, Shumaker SA, Snyder TE, Furberg CD, Kowalchuk GJ, Stuckey TD, Rogers WJ, Givens DH, Waters D. Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. N Engl J Med. 2000 Aug 24;343(8):522-9. doi: 10.1056/NEJM200008243430801.
PubMed 10954759
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Estrogen Replacement and Atherosclerosis Trial
- ClinicalTrials.gov ID
- NCT03097120
- Acronym / sponsor ID
- ERA / U01HL45488
- Conditions
- Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 1995
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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.
Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects.
Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| unopposed estrogen | Active comparator | Drug: 0.625 mg of conjugated equine estrogen0.625 mg of conjugated equine estrogen |
| estrogen-plus-medroxyprogesterone | Active comparator | Drug: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate |
| placebo | Placebo comparator | Drug: placebo tabletsplacebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- postmenopausal
- not currently receiving estrogen-replacement treatment
- one or more epicardial coronary stenoses of at least 30 percent of the luminal diameter, as measured by quantitative coronary angiography
Key exclusion criteria (10 listed)
- known or suspected breast or endometrial carcinoma
- previous or planned coronary-artery bypass surgery,
- a history of deep-vein thrombosis or pulmonary embolism,
- symptomatic gallstones,
- serum aspartate aminotransferase level more than 1.5 times the normal value,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.625 mg of conjugated equine estrogenone tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily | Drug | unopposed estrogen |
| 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetateone tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily | Drug | estrogen-plus-medroxyprogesterone |
| placebo tabletstwo placebo tablets daily | Drug | placebo |
Primary outcome
mean minimal coronary-artery diameter
Time frame: at average of 3.2 years follow-up
mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis
3 secondary outcomes
stenosis as a percentage of the reference diameter
Time frame: at average of 3.2 years follow-up
development of new lesions in a patient
Time frame: at average of 3.2 years follow-up
Models focusing on change in diameter were also examined
Time frame: at average of 3.2 years follow-up
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 22 May 2023.
- Background: PubMed 10822123Herrington DM, Reboussin DM, Klein KP, Sharp PC, Shumaker SA, Snyder TE, Geisinger KR. The estrogen replacement and atherosclerosis (ERA) study: study design and baseline characteristics of the cohort. Control Clin Trials. 2000 Jun;21(3):257-85. doi: 10.1016/s0197-2456(00)00054-4.
- Results publication: PubMed 10954759Herrington DM, Reboussin DM, Brosnihan KB, Sharp PC, Shumaker SA, Snyder TE, Furberg CD, Kowalchuk GJ, Stuckey TD, Rogers WJ, Givens DH, Waters D. Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. N Engl J Med. 2000 Aug 24;343(8):522-9. doi: 10.1056/NEJM200008243430801.
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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.
David M. Herrington, MD, MHS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.625 mg of conjugated equine estrogen and 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate in people with Heart Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
mean minimal coronary-artery diameter (time frame: at average of 3.2 years follow-up). 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 NCT03097120, which also lists 2 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 22 May 2023.