Cardiovascular DiseasesPhase 3NCT00000488
Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)
A Phase 3 study testing cholestyramine and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 59 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- cholestyramine and diet, fat-restricted
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1973to Oct 1989
- 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 35 to 59 years
- Men only
- No healthy volunteers
- Adult
Men, ages 35-59. Type II hyperlipoproteinemia. Free from coronary heart disease.
About this study
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.
Read the detailed description
BACKGROUND:
Numerous prospective epidemiologic studies have demonstrated that hypercholesterolemia is a major risk factor for atherosclerotic coronary heart disease. Research on animals indicating that the reduction of serum cholesterol prevented or reversed atherosclerosis had not been shown convincingly in humans. The Coronary Primary Prevention Trial tested the hypothesis that lowering the serum cholesterol in patients who had no existing evidence of coronary heart disease would reduce the subsequent rate of coronary heart disease in those persons.
Coronary heart disease is the leading cause of death and a major cause of morbidity in the United States. The very slow development of the underlying arterial disease and its frequently sudden onset and quickly fatal course necessitate a preventive approach if substantial inroads are to be made. The positive result from the Coronary Primary Prevention Trial (CPPT) has done much to resolve the controversy regarding the benefits of lipid-lowering, and should lead to firm advice for high-risk hypercholesterolemic subjects and for the population as a whole.
The CPPT was part of the Institute's Lipid Research Clinic Program under the Lipid Metabolism Branch, DHVD, NHLBI. Twelve lipid research clinics in the United States and Canada participated in this trial, as well as a coordinating center, a central electrocardiographic laboratory, central lipid and clinical chemistry laboratories, a nutrition coding center, and a group of consultants on recruitment and adherence. This program's objectives included the development of standardized methods and definitions for the diagnosis of hyperlipoproteinemia and the performance of a series of collaborative studies of the prevalence and natural history of this disorder, as well as the design and implementation of the Coronary Primary Prevention Trial.
The protocol for the trial was approved in November 1972. Beginning in July 1973, men with hypercholesterolemia were recruited as potential trial subjects from such diverse sources as physician referrals, blood bank donor lists, and mass screening programs. Each subject was screened further in a series of four visits, the purpose of which was to select only men (1) whose lipid abnormality was of the primary Type II phenotype, (2) who were free of clinically manifest coronary heart disease, and (3) whose excellent overall health and reliability made 7-10 years of follow-up a realistic objective. Additionally, a standardized limited-cholesterol/saturated fat diet was initiated at the second of these visits in order to exclude men whose cholesterol levels were highly responsive to diet. Subjects who met all the selection criteria were randomly assigned, in a double-blind fashion, to receive either the cholesterol-lowering drug cholestyramine or a placebo at their fifth visit.
Recruitment of the 3,806 CPPT subjects was completed in July 1976. After randomization into the study, each subject visited his clinic at bimonthly intervals. At these visits, adherence to drug and diet were assessed, the study medication was supplied, general health and potential toxic side effects were monitored, and intervening cardiovascular events were recorded. Counseling in drug and dietary adherence were given at each visit, and medical advice was given when a problem was identified. Trial data were collected and analyzed at the Central Patient Registry and reviewed periodically by a Safety and Data Monitoring Board. Intervention ceased between May and August 1983. A five-year follow-up was initiated in November 1984 to detect possible toxicity in the CPPT participants following ingestion of cholestyramine (or placebo) for 7 to 10 years. Follow-up was completed in October 1989.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample size with one experimental group and one control group of equal size. Experimental group on diet and lipid-lowering drug regimen; control group on diet and placebo regimen.
- Being tested
- cholestyramine, diet, fat-restricted
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholestyramineDrug
diet, fat-restrictedBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJun 1973
- Study completionOct 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Francois Abboud, University of IowaElizabeth Barrett-Connor, University of California, San DiegoReagan Bradford, Oklahoma Medical Research FoundationMarilyn Buzzard, University of MinnesotaGerald Cooper, Centers for Disease Control and PreventionJohn Farquhar, Stanford UniversityIvan Frantz, University of MinnesotaAnne Goldberg, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000488
- Sponsor's protocol ID
- 7
- Status last verified
- Apr 2012
- First submitted
- 27 Oct 1999
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
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.
PubMed 489702Agras 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.
PubMed 373955Rifkind 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.
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.
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.
PubMed 7127710Gordon 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.
PubMed 7181738Gordon 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.
PubMed 6821893Pre-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.
PubMed 6863470The 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.
PubMed 6361299The 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.
PubMed 6361300Rifkind 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.
PubMed 6382999Gordon 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.
PubMed 6465119NHLBI workshop on the Lipid Research Clinics Coronary Primary Prevention Trial. Arteriosclerosis. 1985 Jul-Aug;5(4):397-403. No abstract available.
PubMed 3893403Rifkind BM. The Lipid Research Clinics Coronary Primary Prevention Trial: results and implications. Monogr Atheroscler. 1985;13:74-84. No abstract available.
PubMed 3911061Rifkind 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)
- ClinicalTrials.gov ID
- NCT00000488
- Acronym / sponsor ID
- 7
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1973
- Study completion
- Oct 1989 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Numerous prospective epidemiologic studies have demonstrated that hypercholesterolemia is a major risk factor for atherosclerotic coronary heart disease. Research on animals indicating that the reduction of serum cholesterol prevented or reversed atherosclerosis had not been shown convincingly in humans. The Coronary Primary Prevention Trial tested the hypothesis that lowering the serum cholesterol in patients who had no existing evidence of coronary heart disease would reduce the subsequent rate of coronary heart disease in those persons.
Coronary heart disease is the leading cause of death and a major cause of morbidity in the United States. The very slow development of the underlying arterial disease and its frequently sudden onset and quickly fatal course necessitate a preventive approach if substantial inroads are to be made. The positive result from the Coronary Primary Prevention Trial (CPPT) has done much to resolve the controversy regarding the benefits of lipid-lowering, and should lead to firm advice for high-risk hypercholesterolemic subjects and for the population as a whole.
The CPPT was part of the Institute's Lipid Research Clinic Program under the Lipid Metabolism Branch, DHVD, NHLBI. Twelve lipid research clinics in the United States and Canada participated in this trial, as well as a coordinating center, a central electrocardiographic laboratory, central lipid and clinical chemistry laboratories, a nutrition coding center, and a group of consultants on recruitment and adherence. This program's objectives included the development of standardized methods and definitions for the diagnosis of hyperlipoproteinemia and the performance of a series of collaborative studies of the prevalence and natural history of this disorder, as well as the design and implementation of the Coronary Primary Prevention Trial.
The protocol for the trial was approved in November 1972. Beginning in July 1973, men with hypercholesterolemia were recruited as potential trial subjects from such diverse sources as physician referrals, blood bank donor lists, and mass screening programs. Each subject was screened further in a series of four visits, the purpose of which was to select only men (1) whose lipid abnormality was of the primary Type II phenotype, (2) who were free of clinically manifest coronary heart disease, and (3) whose excellent overall health and reliability made 7-10 years of follow-up a realistic objective. Additionally, a standardized limited-cholesterol/saturated fat diet was initiated at the second of these visits in order to exclude men whose cholesterol levels were highly responsive to diet. Subjects who met all the selection criteria were randomly assigned, in a double-blind fashion, to receive either the cholesterol-lowering drug cholestyramine or a placebo at their fifth visit.
Recruitment of the 3,806 CPPT subjects was completed in July 1976. After randomization into the study, each subject visited his clinic at bimonthly intervals. At these visits, adherence to drug and diet were assessed, the study medication was supplied, general health and potential toxic side effects were monitored, and intervening cardiovascular events were recorded. Counseling in drug and dietary adherence were given at each visit, and medical advice was given when a problem was identified. Trial data were collected and analyzed at the Central Patient Registry and reviewed periodically by a Safety and Data Monitoring Board. Intervention ceased between May and August 1983. A five-year follow-up was initiated in November 1984 to detect possible toxicity in the CPPT participants following ingestion of cholestyramine (or placebo) for 7 to 10 years. Follow-up was completed in October 1989.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample size with one experimental group and one control group of equal size. Experimental group on diet and lipid-lowering drug regimen; control group on diet and placebo regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholestyramine | Drug | – |
| diet, fat-restricted | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 489702The 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.
- Background: PubMed 373955Agras 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.
- BackgroundRifkind 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.
- BackgroundKnopp 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: PubMed 7127710Recruitment 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.
- Background: PubMed 7181738Gordon 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.
- Background: PubMed 6821893Gordon 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.
- Background: PubMed 6863470Pre-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.
- Background: PubMed 6361299The 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.
- Background: PubMed 6361300The 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.
- Background: PubMed 6382999Rifkind 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.
- Background: PubMed 6465119Gordon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Abboud
University of Iowa
Elizabeth Barrett-Connor
University of California, San Diego
Reagan Bradford
Oklahoma Medical Research Foundation
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cholestyramine and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000488, which also lists 32 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 14 Apr 2016.