Raloxifene Use for The Heart

Phase 3

Completed

• Conditions: Cardiovascular Diseases; Breast Neoplasms

• Registration Number: NCT00190593
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2005-11
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

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