NHLBI Type II Coronary Intervention Study
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
cholestyramine
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Men and women with angiographically demonstrated coronary artery disease.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000594
First Posted
October 27, 1999
Last Updated
April 26, 2012
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000594
Brief Title
NHLBI Type II Coronary Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 1971 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1976 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypercholesterolemia, Familial, Myocardial Infarction, Myocardial Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cholestyramine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women with angiographically demonstrated coronary artery disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Brensike
Organizational Affiliation
Cardiology Branch, NHLBI
12. IPD Sharing Statement
Citations:
PubMed Identifier
168493
Citation
Borer JS, Brensike JF, Redwood DR, Itscoitz SB, Passamani ER, Stone NJ, Richardson JM, Levy RI, Epstein SE. Limitations of the electrocardiographic response to exercise in predicting coronary-artery disease. N Engl J Med. 1975 Aug 21;293(8):367-71. doi: 10.1056/NEJM197508212930801.
Results Reference
background
PubMed Identifier
190398
Citation
Belmaker RH, Pollin W, Jenkins CD, Brensike J. Coronary prone behavior pattern in a sample of type II hypercholesteremic patients. J Psychosom Res. 1976;20(6):591-4. doi: 10.1016/0022-3999(76)90061-1. No abstract available.
Results Reference
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PubMed Identifier
582024
Citation
Aldrich RF, Brensike JF, Battaglini JW, Richardson JM, Loh IK, Stone NJ, Passamani ER, Ackerstein H, Seningen R, Borer JS, Levy RI, Epstein SE. Coronary calcifications in the detection of coronary artery disease and comparison with electrocardiographic exercise testing. Results from the National Heart, Lung, and Blood Institute's type II coronary intervention study. Circulation. 1979 Jun;59(6):1113-24. doi: 10.1161/01.cir.59.6.1113. No abstract available.
Results Reference
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PubMed Identifier
6749427
Citation
Brensike JF, Kelsey SF, Passamani ER, Fisher MR, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarty DJ, Myrianthopoulos MB, Detre KM, Epstein SE, Levy RI. National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline characteristics. Control Clin Trials. 1982 Jun;3(2):91-111. doi: 10.1016/0197-2456(82)90038-1.
Results Reference
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PubMed Identifier
6360414
Citation
Brensike JF, Levy RI, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarty DJ, et al. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984 Feb;69(2):313-24. doi: 10.1161/01.cir.69.2.313.
Results Reference
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PubMed Identifier
6360415
Citation
Levy RI, Brensike JF, Epstein SE, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, et al. The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary artery disease: results of NHLBI Type II Coronary Intervention Study. Circulation. 1984 Feb;69(2):325-37. doi: 10.1161/01.cir.69.2.325.
Results Reference
background
PubMed Identifier
2912435
Citation
Brown BG, Lin JT, Kelsey S, Passamani ER, Levy RI, Dodge HT, Detre KM. Progression of coronary atherosclerosis in patients with probable familial hypercholesterolemia. Quantitative arteriographic assessment of patients in NHLBI type II study. Arteriosclerosis. 1989 Jan-Feb;9(1 Suppl):I81-90.
Results Reference
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NHLBI Type II Coronary Intervention Study
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