Breast Neoplasms, Cardiovascular Diseases
Conditions
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.
Interventions
DRUGplacebo
DRUGraloxifene
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| All-cause hospitalization and mortality | — |
| Non-coronary artery revascularization | — |
| After an expected 5 to 7.5 years of follow-up: | — |
| Fractures | — |
| Venous thromboembolism. | — |
| Non-traumatic lower extremity amputation | — |
| Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined) | — |
Countries
United States
Outcome results
None listed