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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000594 |
To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.
Condition | Intervention | Phase |
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Cardiovascular Diseases Coronary Disease Heart Diseases Hypercholesterolemia, Familial Myocardial Infarction Myocardial Ischemia |
Drug: cholestyramine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind |
Study Start Date: | November 1971 |
BACKGROUND:
There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. It should be noted that patients in the CPPT did not have known preexisting coronary heart disease.
DESIGN NARRATIVE:
A randomized, double-blind trial, with single experimental and control groups. The experimental group received drug therapy (cholestyramine); the control group received placebo. Both groups received diet therapy. The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. Patients were followed under therapy for at least 5 years.
Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women with angiographically demonstrated coronary artery disease.
Study ID Numbers: | 400 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000594 |
Health Authority: | United States: Federal Government |
Lipid Metabolism, Inborn Errors Arterial Occlusive Diseases Cholestyramine Metabolic Diseases Hyperlipidemias Heart Diseases Myocardial Ischemia Hyperlipoproteinemia Type II Vascular Diseases Ischemia Arteriosclerosis Coronary Disease |
Metabolism, Inborn Errors Necrosis Genetic Diseases, Inborn Metabolic disorder Infarction Myocardial Infarction Hypercholesterolemia Dyslipidemias Coronary Artery Disease Hyperlipoproteinemias Lipid Metabolism Disorders |
Antimetabolites Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Cardiovascular Diseases Anticholesteremic Agents Pharmacologic Actions |