Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-15 @ 2:50 PM
Study NCT ID:
NCT03097120
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2011-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], 'ancestors': [{'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 309}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2011-04-26', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean minimal coronary-artery diameter', 'timeFrame': 'at average of 3.2 years follow-up', 'description': 'mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis'}], 'secondaryOutcomes': [{'measure': 'stenosis as a percentage of the reference diameter', 'timeFrame': 'at average of 3.2 years follow-up'}, {'measure': 'development of new lesions in a patient', 'timeFrame': 'at average of 3.2 years follow-up'}, {'measure': 'Models focusing on change in diameter were also examined', 'timeFrame': 'at average of 3.2 years follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Disease']}, 'referencesModule': {'references': [{'pmid': '10822123', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10954759', 'type': 'RESULT', 'citation': 'Herrington 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal\n* not currently receiving estrogen-replacement treatment\n* one or more epicardial coronary stenoses of at least 30 percent of the luminal diameter, as measured by quantitative coronary angiography\n\nExclusion Criteria:\n\n* known or suspected breast or endometrial carcinoma\n* previous or planned coronary-artery bypass surgery,\n* a history of deep-vein thrombosis or pulmonary embolism,\n* symptomatic gallstones,\n* serum aspartate aminotransferase level more than 1.5 times the normal value,\n* fasting triglyceride level of more than 400 mg per deciliter\n* serum creatinine level of more than 2.0 mg per deciliter\n* more than 70 percent stenosis of the left main coronary artery,\n* uncontrolled hypertension, or\n* uncontrolled diabetes.'}, 'identificationModule': {'nctId': 'NCT03097120', 'acronym': 'ERA', 'briefTitle': 'The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Estrogen Replacement and Atherosclerosis Trial', 'orgStudyIdInfo': {'id': 'U01HL45488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'unopposed estrogen', 'description': '0.625 mg of conjugated equine estrogen', 'interventionNames': ['Drug: 0.625 mg of conjugated equine estrogen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'estrogen-plus-medroxyprogesterone', 'description': '0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate', 'interventionNames': ['Drug: 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: placebo tablets']}], 'interventions': [{'name': '0.625 mg of conjugated equine estrogen', 'type': 'DRUG', 'description': 'one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily', 'armGroupLabels': ['unopposed estrogen']}, {'name': '0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate', 'type': 'DRUG', 'description': 'one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily', 'armGroupLabels': ['estrogen-plus-medroxyprogesterone']}, {'name': 'placebo tablets', 'type': 'DRUG', 'description': 'two placebo tablets daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David M. Herrington, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}