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OpenTrials
Completed

NCT Number: NCT00190593

Raloxifene Use for The Heart

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.

Completed

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Key information

Conditions

Cardiovascular Diseases Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Raloxifene

Drug

Placebo

Drug

Primary outcomes

  1. 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.

  2. Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.

Secondary outcomes

  1. After an expected 5 to 7.5 years of follow-up:

  2. Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)

  3. All-cause hospitalization and mortality

  4. Non-coronary artery revascularization

  5. Non-traumatic lower extremity amputation

  6. Fractures

  7. Venous thromboembolism.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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