Cardiovascular Diseases Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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