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Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) Clinical research trials and Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Lipid Research Clinics Coronary Primary Prevention Trial (CPPT). Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) clinical trial. Participants oftentimes recieve the most expert healthcare available for their Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)  Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)
Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)
For Condition: Cardiovascular Diseases,Coronary Disease,Heart Diseases,Myocardial Ischemia
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind
Minimum Age/Maximum Age: 35 Years/59 Years
Genders: Male
Protocol Entry Criteria: Men, ages 35-59. Type II hyperlipoproteinemia. Free from coronary heart disease.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancoisAbboud, , University of Iowa
Additional Information:
Study ID Numbers: 7;
Study Start Date: June 1973
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000488
Other Cardiovascular Diseases Studies:
1. Dietary Approaches to Stop Hypertension (DASH)
2. Epidemiology of Decline in Heart Disease Mortality
3. IN CONTROL--Hypertension Reduction in Inner City Seattle
4. Pawtucket Heart Health Program
5. Community Site Coronary Risk Control in Black Families
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Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)
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