Raloxifene Use for The Heart

Phase 3CompletedNCT00190593

Eli Lilly and Company10,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

10,000

Conditions

Cardiovascular Diseases Breast Neoplasms

Interventions

raloxifeneDRUG

placeboDRUG

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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.

Locations (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

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.

Data from ClinicalTrials.gov

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