NHLBI Type II Coronary Intervention Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Dyslipidemias Genetic Diseases, Inborn Heart Diseases Hypercholesterolemia, Familial Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Infarction Ischemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Myocardial Infarction Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Men and women with angiographically demonstrated coronary artery disease.

Treatment and study plan

Cholestyramine

Drug

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 1971
Study completion: 1976
First posted: Oct 28, 1999
Registry last updated: Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed