Raloxifene Use for The Heart

Cardiovascular Diseases Clinical Trial

Official title:

Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190593
• Other study ID #: 1865
• Secondary ID: H3S-MC-GGIO
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: June 1998
• Est. completion date: November 2005

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms
• Cardiovascular Diseases

Intervention

Drug:
• raloxifene

• placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady D, Kornitzer M, McNabb MA, Wenger NK; Raloxifene Use for The Heart (RUTH) Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
Secondary	After an expected 5 to 7.5 years of follow-up:
Secondary	Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
Secondary	All-cause hospitalization and mortality
Secondary	Non-coronary artery revascularization
Secondary	Non-traumatic lower extremity amputation
Secondary	Fractures
Secondary	Venous thromboembolism.