NCT00000477

Brief Summary

To conduct a pilot study to determine whether lowering elevated serum cholesterol levels with 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG CoA) reductase inhibitors reduced mortality due to the sequelae of atherosclerotic cardiovascular disease in older men and women.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1990

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1990

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1992

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

February 18, 2016

Status Verified

June 1, 1992

First QC Date

October 27, 1999

Last Update Submit

February 17, 2016

Conditions

AtherosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesHypercholesterolemiaMyocardial Ischemia

Interventions

lovastatinDRUG

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Men and women, ages 65 and older, with elevated low-density lipoprotein cholesterol levels between 159 and 221 mg/dl at entry.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • Stoy DB, Curtis RC, Dameworth KS, Dowdy AA, Hegland J, Levin JA, Sousoulas BG. The successful recruitment of elderly black subjects in a clinical trial: the CRISP experience. Cholesterol Reduction in Seniors Program. J Natl Med Assoc. 1995 Apr;87(4):280-7.

    PMID: 7752281BACKGROUND

  • Davis CE, Applegate WB, Gordon DJ, Curtis RC, McCormick M. An empirical evaluation of the placebo run-in. Control Clin Trials. 1995 Feb;16(1):41-50. doi: 10.1016/0197-2456(94)00027-z.

    PMID: 7743788BACKGROUND

  • LaRosa JC, Applegate W, Crouse JR 3rd, Hunninghake DB, Grimm R, Knopp R, Eckfeldt JH, Davis CE, Gordon DJ. Cholesterol lowering in the elderly. Results of the Cholesterol Reduction in Seniors Program (CRISP) pilot study. Arch Intern Med. 1994 Mar 14;154(5):529-39. doi: 10.1001/archinte.154.5.529.

    PMID: 8122946BACKGROUND

  • Santanello NC, Barber BL, Applegate WB, Elam J, Curtis C, Hunninghake DB, Gordon DJ. Effect of pharmacologic lipid lowering on health-related quality of life in older persons: results from the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study. J Am Geriatr Soc. 1997 Jan;45(1):8-14. doi: 10.1111/j.1532-5415.1997.tb00971.x.

    PMID: 8994481BACKGROUND

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesHypercholesterolemiaMyocardial Ischemia

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • William Applegate

    University of Tennessee

  • John Crouse

    Bowman Gray School of Medicine

  • Donald Hunninghake

    University of Minnesota

  • Robert Knopp

    University of Washington

  • John LaRosa

    George Washington University

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1990

Study Completion

June 1, 1992

Last Updated

February 18, 2016

Record last verified: 1992-06