Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00190593
Status:
COMPLETED
Last Update Posted:
2007-01-26
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Raloxifene Use for The Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 10000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2007-01-24', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.'}, {'measure': 'Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'After an expected 5 to 7.5 years of follow-up:'}, {'measure': 'Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)'}, {'measure': 'All-cause hospitalization and mortality'}, {'measure': 'Non-coronary artery revascularization'}, {'measure': 'Non-traumatic lower extremity amputation'}, {'measure': 'Fractures'}, {'measure': 'Venous thromboembolism.'}]}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '12450599', 'type': 'BACKGROUND', 'citation': 'Wenger NK, Barrett-Connor E, Collins P, Grady D, Kornitzer M, Mosca L, Sashegyi A, Baygani SK, Anderson PW, Moscarelli E. Baseline characteristics of participants in the Raloxifene Use for The Heart (RUTH) trial. Am J Cardiol. 2002 Dec 1;90(11):1204-10. doi: 10.1016/s0002-9149(02)02835-7.'}, {'pmid': '11545760', 'type': 'BACKGROUND', 'citation': 'Mosca L, Barrett-Connor E, Wenger NK, Collins P, Grady D, Kornitzer M, Moscarelli E, Paul S, Wright TJ, Helterbrand JD, Anderson PW. Design and methods of the Raloxifene Use for The Heart (RUTH) study. Am J Cardiol. 2001 Aug 15;88(4):392-5. doi: 10.1016/s0002-9149(01)01685-x.'}, {'pmid': '16837676', 'type': 'RESULT', 'citation': 'Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady D, Kornitzer M, McNabb MA, Wenger NK; Raloxifene Use for The Heart (RUTH) Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006 Jul 13;355(2):125-37. doi: 10.1056/NEJMoa062462.'}, {'pmid': '23481531', 'type': 'DERIVED', 'citation': 'Daniels LB, Grady D, Mosca L, Collins P, Mitlak BH, Amewou-Atisso MG, Wenger NK, Barrett-Connor E; Raloxifene Use for the Heart (RUTH) Trial Investigators. Is diabetes mellitus a heart disease equivalent in women? Results from an international study of postmenopausal women in the Raloxifene Use for the Heart (RUTH) Trial. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):164-70. doi: 10.1161/CIRCOUTCOMES.112.966986. Epub 2013 Mar 12.'}, {'pmid': '19204301', 'type': 'DERIVED', 'citation': 'Collins P, Mosca L, Geiger MJ, Grady D, Kornitzer M, Amewou-Atisso MG, Effron MB, Dowsett SA, Barrett-Connor E, Wenger NK. Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors. Circulation. 2009 Feb 24;119(7):922-30. doi: 10.1161/CIRCULATIONAHA.108.817577. Epub 2009 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women with established coronary heart disease or at risk for a major coronary event.\n\nExclusion Criteria:\n\n* Postmenopausal symptoms that required estrogen replacement therapy.\n* Suspected or known history of breast or endometrial carcinoma.\n* Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis.\n* New York Heart Association classes III or IV heart failure.'}, 'identificationModule': {'nctId': 'NCT00190593', 'briefTitle': 'Raloxifene Use for The Heart', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events', 'orgStudyIdInfo': {'id': '1865'}, 'secondaryIdInfos': [{'id': 'H3S-MC-GGIO'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'raloxifene', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'For additonal information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}