NCT00190593CompletedPhase 3
Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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 Outcomes
- 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.
Investigators
Study Sites (1)
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