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Home > "N" Clinical Trials Conditions > NHLBI Type II Coronary Intervention Study  NHLBI Type II Coronary Intervention Study
NHLBI Type II Coronary Intervention Study
For Condition: Cardiovascular Diseases,Coronary Disease,Heart Diseases,Hypercholesterolemia, Familial,Myocardial Infarction,Myocardial Ischemia
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind
Minimum Age/Maximum Age: 21 Years/55 Years
Genders: Both
Protocol Entry Criteria: Men and women with angiographically demonstrated coronary artery disease.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnBrensike, , Cardiology Branch, NHLBI
Additional Information:
Study ID Numbers: 400;
Study Start Date: November 1971
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000594
Other Myocardial Infarction Studies:
1. Montreal Heart Attack Readjustment Trial (M-HART)
2. Stanford Five-City Multifactor Risk Reduction Study
3. Rapid Early Action for Coronary Treatment (REACT)
4. Azithromycin and Coronary Events Study (ACES)
5. Harvard Atherosclerosis Reversibility Project (HARP)
Related Studies:
Other Myocardial Infarction Clinical Trials
Other Clinical Trials
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NHLBI Type II Coronary Intervention Study
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