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NHLBI Type II Coronary Intervention Study
This study has been completed.
Study NCT00000594   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: October 27, 1999   Last Updated: June 23, 2005   History of Changes

October 27, 1999
June 23, 2005
November 1971
 
 
 
Complete list of historical versions of study NCT00000594 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase III
Interventional
Prevention, Randomized, Double-Blind
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Hypercholesterolemia, Familial
  • Myocardial Infarction
  • Myocardial Ischemia
Drug: cholestyramine
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

Men and women with angiographically demonstrated coronary artery disease.

Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00000594
 
400
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: John Brensike Cardiology Branch, NHLBI
National Heart, Lung, and Blood Institute (NHLBI)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP