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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Men and women with angiographically demonstrated coronary artery disease.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    April 26, 2012
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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
    background
    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
    background
    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
    background
    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
    background
    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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