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Cardiovascular DiseasesPhase 3NCT00190593

Raloxifene Use for The Heart

A Phase 3 study testing raloxifene in people with Cardiovascular Diseases and Breast Neoplasms, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and older, women only
Conditions the study is for
Cardiovascular Diseases, Breast Neoplasms
What is being tested?
raloxifene
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,000 participants
Where
1 siteUnited States
Study dates
Jun 1998to Nov 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women with established coronary heart disease or at risk for a major coronary event.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • 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

Other trials in United States

About this study

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

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.

Being tested
raloxifene, placebo
Medical subject headings
Cardiovascular Diseases, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • raloxifeneDrug

  • placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (7)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startJun 1998
  3. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
10,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00190593
Sponsor's protocol ID
1865
Other IDs
H3S-MC-GGIO
Status last verified
Jan 2007
First submitted
12 Sep 2005
Last updated
26 Jan 2007
Results posted
No

Publications

  • 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. doi: 10.1016/s0002-9149(02)02835-7.

    PubMed 12450599

  • 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. doi: 10.1016/s0002-9149(01)01685-x.

    PubMed 11545760

  • 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. 2006 Jul 13;355(2):125-37. doi: 10.1056/NEJMoa062462.

    PubMed 16837676

  • Daniels LB, Grady D, Mosca L, Collins P, Mitlak BH, Amewou-Atisso MG, Wenger NK, Barrett-Connor E; Raloxifene Use for the Heart (RUTH) Trial Investigators. Is diabetes mellitus a heart disease equivalent in women? Results from an international study of postmenopausal women in the Raloxifene Use for the Heart (RUTH) Trial. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):164-70. doi: 10.1161/CIRCOUTCOMES.112.966986. Epub 2013 Mar 12.

    PubMed 23481531

  • Collins P, Mosca L, Geiger MJ, Grady D, Kornitzer M, Amewou-Atisso MG, Effron MB, Dowsett SA, Barrett-Connor E, Wenger NK. Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors. Circulation. 2009 Feb 24;119(7):922-30. doi: 10.1161/CIRCULATIONAHA.108.817577. Epub 2009 Feb 9.

    PubMed 19204301

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing raloxifene in people with Cardiovascular Diseases and Breast Neoplasms, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00190593, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2007.

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