NCT00000488

Brief Summary

To determine whether reduction of cholesterol by drug therapy significantly lowered the atherosclerotic coronary heart disease rate in a group of hypercholesterolemic but otherwise healthy men. Total dollars spent on the CPPT from June 1973 were $142,250,000. We do not have a year-by-year breakdown.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1973

Longer than P75 for phase_3 cardiovascular-diseases

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

June 1, 1973

Completed
16.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1989

Completed
10.1 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

April 14, 2016

Status Verified

April 1, 2012

First QC Date

October 27, 1999

Last Update Submit

April 13, 2016

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

cholestyramineDRUG
diet, fat-restrictedBEHAVIORAL

Eligibility Criteria

Age35 Years - 59 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Men, ages 35-59. Type II hyperlipoproteinemia. Free from coronary heart disease.

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

Sponsors & Collaborators

Related Publications (32)

  • The coronary primary prevention trial: design and implementation: the Lipid Research Clinics Program. J Chronic Dis. 1979;32(9-10):609-31. doi: 10.1016/0021-9681(79)90092-4. No abstract available.

    PMID: 489702BACKGROUND

  • Agras WS, Marshall G. Recruitment for the Coronary Primary Prevention Trial. Clin Pharmacol Ther. 1979 May;25(5 Pt 2):688-90. doi: 10.1002/cpt1979255part2688.

    PMID: 373955BACKGROUND

  • Rifkind B, Goor R: The Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT). Drugs Affecting Lipid Metabolism, l5l-l57, Fumagalli R, Kritchevsky D, Paoletti R (Eds): Elsevier/North-Holland Biomedical Press, l980.

    BACKGROUND

  • Knopp RH: Test of the Lipid Hypothesis: The Coronary Primary Prevention Trial (CPPT) of the Lipid Research Clinics Program. Proceedings of the Fifth International Symposium on Atherosclerosis, 509-512, Gotto, AM, Jr. (Ed.): Springer-Verlag, 1980.

    BACKGROUND

  • Recruitment for clinical trials: the Lipid Research Clinics Coronary Primary Prevention Trial experience. Its implications for future trials. Circulation. 1982 Dec;66(6 Pt 2):IV1-78. No abstract available.

    PMID: 7127710BACKGROUND

  • Gordon DJ, Salz KM, Roggenkamp KJ, Franklin FA Jr. Dietary determinants of plasma cholesterol change in the recruitment phase of the Lipid Research Clinics Coronary Primary Prevention Trial. Arteriosclerosis. 1982 Nov-Dec;2(6):537-48. doi: 10.1161/01.atv.2.6.537.

    PMID: 7181738BACKGROUND

  • Gordon DJ, Witztum JL, Hunninghake D, Gates S, Glueck CJ. Habitual physical activity and high-density lipoprotein cholesterol in men with primary hypercholesterolemia. The Lipid Research Clinics Coronary Primary Prevention Trial. Circulation. 1983 Mar;67(3):512-20. doi: 10.1161/01.cir.67.3.512.

    PMID: 6821893BACKGROUND

  • Pre-entry characteristics of participants in the Lipid Research Clinics' Coronary Primary Prevention Trial. J Chronic Dis. 1983;36(6):467-79. doi: 10.1016/0021-9681(83)90138-8.

    PMID: 6863470BACKGROUND

  • The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA. 1984 Jan 20;251(3):351-64. doi: 10.1001/jama.1984.03340270029025.

    PMID: 6361299BACKGROUND

  • The Lipid Research Clinics Coronary Primary Prevention Trial results. II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA. 1984 Jan 20;251(3):365-74.

    PMID: 6361300BACKGROUND

  • Rifkind BM. Lipid Research Clinics Coronary Primary Prevention Trial: results and implications. Am J Cardiol. 1984 Aug 27;54(5):30C-34C. doi: 10.1016/0002-9149(84)90854-3.

    PMID: 6382999BACKGROUND

  • Gordon DJ, Probstfield JL, Rubenstein C, Bremner WF, Leon AS, Karon JM, Third J, Bryan H, Schwartz L, Insull W, et al. Coronary risk factors and exercise test performance in asymptomatic hypercholesterolemic men: application of proportional hazards analysis. Am J Epidemiol. 1984 Aug;120(2):210-24. doi: 10.1093/oxfordjournals.aje.a113883.

    PMID: 6465119BACKGROUND

  • NHLBI workshop on the Lipid Research Clinics Coronary Primary Prevention Trial. Arteriosclerosis. 1985 Jul-Aug;5(4):397-403. No abstract available.

    PMID: 3893403BACKGROUND

  • Rifkind BM. The Lipid Research Clinics Coronary Primary Prevention Trial: results and implications. Monogr Atheroscler. 1985;13:74-84. No abstract available.

    PMID: 3911061BACKGROUND

  • Rifkind BM: The Lipid Research Clinics Coronary Primary Prevention Trial. In Shepherd G, et al (Eds). Lipoproteins and Coronary Heart Disease. London and Glasgow. Blantyre Printing Ltd.:109, 1986.

    BACKGROUND

  • Gordon DJ, Knoke J, Probstfield JL, Superko R, Tyroler HA. High-density lipoprotein cholesterol and coronary heart disease in hypercholesterolemic men: the Lipid Research Clinics Coronary Primary Prevention Trial. Circulation. 1986 Dec;74(6):1217-25. doi: 10.1161/01.cir.74.6.1217.

    PMID: 3536151BACKGROUND

  • Glueck CJ, Gordon DJ, Nelson JJ, Davis CE, Tyroler HA. Dietary and other correlates of changes in total and low density lipoprotein cholesterol in hypercholesterolemic men: the lipid research clinics coronary primary prevention trial. Am J Clin Nutr. 1986 Oct;44(4):489-500. doi: 10.1093/ajcn/44.4.489.

    PMID: 3532756BACKGROUND

  • Gordon DJ, Leon AS, Ekelund LG, Sopko G, Probstfield JL, Rubenstein C, Sheffield LT. Smoking, physical activity, and other predictors of endurance and heart rate response to exercise in asymptomatic hypercholesterolemic men. The Lipid Research Clinics Coronary Primary Prevention Trial. Am J Epidemiol. 1987 Apr;125(4):587-600. doi: 10.1093/oxfordjournals.aje.a114572.

    PMID: 3826039BACKGROUND

  • Knoke JD, Hunninghake DB, Heiss G. Physiological markers of smoking and their relation to coronary heart disease. The Lipid Research Clinics Coronary Primary Prevention Trial. Arteriosclerosis. 1987 Sep-Oct;7(5):477-82. doi: 10.1161/01.atv.7.5.477.

    PMID: 3675307BACKGROUND

  • Bradford RH. Participant recruitment to the Lipid Research Clinics Coronary Primary Prevention Trial. Control Clin Trials. 1987 Dec;8(4 Suppl):31S-40S. doi: 10.1016/0197-2456(87)90005-5.

    PMID: 3440388BACKGROUND

  • Gordon DJ, Trost DC, Hyde J, Whaley FS, Hannan PJ, Jacobs DR Jr, Ekelund LG. Seasonal cholesterol cycles: the Lipid Research Clinics Coronary Primary Prevention Trial placebo group. Circulation. 1987 Dec;76(6):1224-31. doi: 10.1161/01.cir.76.6.1224.

    PMID: 3315294BACKGROUND

  • Gordon DJ, Hyde J, Trost DC, Whaley FS, Hannan PJ, Jacobs DR, Ekelund LG. Cyclic seasonal variation in plasma lipid and lipoprotein levels: the Lipid Research Clinics Coronary Primary Prevention Trial Placebo Group. J Clin Epidemiol. 1988;41(7):679-89. doi: 10.1016/0895-4356(88)90120-5.

    PMID: 3294350BACKGROUND

  • Brook JG, Rifkind BM. The Lipid Research Clinics Primary Prevention Trial and its aftermath. Prog Clin Biol Res. 1988;255:7-14. No abstract available.

    PMID: 3277205BACKGROUND

  • Siscovick DS, Ekelund LG, Hyde JS, Johnson JL, Gordon DJ, LaRosa JC. Physical activity and coronary heart disease among asymptomatic hypercholesterolemic men (the Lipid Research Clinics Coronary Primary Prevention Trial). Am J Public Health. 1988 Nov;78(11):1428-31. doi: 10.2105/ajph.78.11.1428.

    PMID: 3052114BACKGROUND

  • Ekelund LG, Suchindran CM, McMahon RP, Heiss G, Leon AS, Romhilt DW, Rubenstein CL, Probstfield JL, Ruwitch JF. Coronary heart disease morbidity and mortality in hypercholesterolemic men predicted from an exercise test: the Lipid Research Clinics Coronary Primary Prevention Trial. J Am Coll Cardiol. 1989 Sep;14(3):556-63. doi: 10.1016/0735-1097(89)90092-2.

    PMID: 2768706BACKGROUND

  • Probstfield JL, Rifkind BM. The Lipid Research Clinics Coronary Primary Prevention Trial: design, results, and implications. Eur J Clin Pharmacol. 1991;40 Suppl 1:S69-75. doi: 10.1007/BF03216294.

    PMID: 2044648BACKGROUND

  • The Lipid Research Clinics Coronary Primary Prevention Trial. Results of 6 years of post-trial follow-up. The Lipid Research Clinics Investigators. Arch Intern Med. 1992 Jul;152(7):1399-410.

    PMID: 1627020BACKGROUND

  • Schaefer EJ, Lamon-Fava S, Jenner JL, McNamara JR, Ordovas JM, Davis CE, Abolafia JM, Lippel K, Levy RI. Lipoprotein(a) levels and risk of coronary heart disease in men. The lipid Research Clinics Coronary Primary Prevention Trial. JAMA. 1994 Apr 6;271(13):999-1003. doi: 10.1001/jama.1994.03510370051031.

    PMID: 8139085BACKGROUND

  • Morris DL, Kritchevsky SB, Davis CE. Serum carotenoids and coronary heart disease. The Lipid Research Clinics Coronary Primary Prevention Trial and Follow-up Study. JAMA. 1994 Nov 9;272(18):1439-41. doi: 10.1001/jama.272.18.1439.

    PMID: 7933426BACKGROUND

  • Participant recruitment to the Coronary Primary Prevention Trial. J Chronic Dis. 1983;36(6):451-65. doi: 10.1016/0021-9681(83)90137-6.

    PMID: 6863469BACKGROUND

  • Probstfield JL, Russell ML, Henske JC, Reardon RJ, Insull W Jr. Successful program for recovery of dropouts to a clinical trial. Am J Med. 1986 May;80(5):777-84. doi: 10.1016/0002-9343(86)90615-7.

    PMID: 3706364BACKGROUND

  • Wanis KN, Madenci AL, Hernan MA, Murray EJ. Adjusting for adherence in randomized trials when adherence is measured as a continuous variable: An application to the Lipid Research Clinics Coronary Primary Prevention Trial. Clin Trials. 2020 Oct;17(5):570-575. doi: 10.1177/1740774520920893. Epub 2020 May 15.

    PMID: 32414298DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

Cholestyramine ResinDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

PolystyrenesPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Francois Abboud

    University of Iowa

  • Elizabeth Barrett-Connor

    University of California, San Diego

  • Reagan Bradford

    Oklahoma Medical Research Foundation

  • Marilyn Buzzard

    University of Minnesota

  • Gerald Cooper

    Centers for Disease Control and Prevention

  • John Farquhar

    Stanford University

  • Ivan Frantz

    University of Minnesota

  • Anne Goldberg

    Washington University School of Medicine

  • Frank Ibbott

    Bio-Science Laboratories

  • William, Insull

    Baylor College of Medicine

  • Robert Knoop

    University of Washington

  • Peter Kwiterovich

    Johns Hopkins University

  • John LaRosa

    George Washington University

  • J. Little

    University of Toronto

  • L. Sheffield

    University of Alabama at Birmingham

  • Dennis Sprecher

    University of Cincinnati

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

June 1, 1973

Study Completion

October 1, 1989

Last Updated

April 14, 2016

Record last verified: 2012-04