Raloxifene Use for The Heart
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00190593
Collaborator
(none)
10,000
1
89
112.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Study Start Date
:
Jun 1, 1998
Study Completion Date
:
Nov 1, 2005
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | Minneapolis | Minnesota | United States |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00190593
Other Study ID Numbers:
- 1865
- H3S-MC-GGIO
First Posted:
Sep 19, 2005
Last Update Posted:
Jan 26, 2007
Last Verified:
Jan 1, 2007