NHLBI Type II Coronary Intervention Study

Cardiovascular Diseases Clinical Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipoproteinemia Type II
• Myocardial Infarction
• Myocardial Ischemia

• NCT number: NCT00000594
• Study type: Interventional
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Status: Completed
• Phase: Phase 3
• Start date: November 1971
• Completion date: November 1976