Back to resultsRaloxifene Use for The Heart
Primary Purpose
Cardiovascular Diseases, Breast Neoplasms
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
raloxifene
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria: Postmenopausal women with established coronary heart disease or at risk for a major coronary event. Exclusion Criteria: Postmenopausal symptoms that required estrogen replacement therapy. Suspected or known history of breast or endometrial carcinoma. Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis. New York Heart Association classes III or IV heart failure.
Sites / Locations
- 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
Outcomes
Primary Outcome Measures
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.
Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
Secondary Outcome Measures
After an expected 5 to 7.5 years of follow-up:
Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
All-cause hospitalization and mortality
Non-coronary artery revascularization
Non-traumatic lower extremity amputation
Fractures
Venous thromboembolism.
Full Information
NCT ID
NCT00190593
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00190593
Brief Title
Raloxifene Use for The Heart
Official Title
Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Breast Neoplasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
10000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
raloxifene
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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.
Title
Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
Secondary Outcome Measure Information:
Title
After an expected 5 to 7.5 years of follow-up:
Title
Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
Title
All-cause hospitalization and mortality
Title
Non-coronary artery revascularization
Title
Non-traumatic lower extremity amputation
Title
Fractures
Title
Venous thromboembolism.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women with established coronary heart disease or at risk for a major coronary event.
Exclusion Criteria:
Postmenopausal symptoms that required estrogen replacement therapy.
Suspected or known history of breast or endometrial carcinoma.
Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis.
New York Heart Association classes III or IV heart failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Minneapolis
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12450599
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.
Results Reference
background
PubMed Identifier
11545760
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.
Results Reference
background
PubMed Identifier
16837676
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.
Results Reference
result
PubMed Identifier
23481531
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.
Results Reference
derived
PubMed Identifier
19204301
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.
Results Reference
derived
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Raloxifene Use for The Heart
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