Nctid:
NCT00000482
Payload:
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{"id"=>"M6549", "name"=>"Coronary Disease", "asFound"=>"Coronary Disease", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "asFound"=>"Heart Disease", "relevance"=>"HIGH"}, {"id"=>"M12284", "name"=>"Necrosis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D009525", "term"=>"Niacin"}, {"id"=>"D002994", "term"=>"Clofibrate"}, {"id"=>"D004967", "term"=>"Estrogens"}], "ancestors"=>[{"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000960", "term"=>"Hypolipidemic Agents"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D057847", "term"=>"Lipid Regulating Agents"}, {"id"=>"D014665", "term"=>"Vasodilator Agents"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}, {"id"=>"D000924", "term"=>"Anticholesteremic Agents"}], "browseLeaves"=>[{"id"=>"M8116", "name"=>"Estrogens", "asFound"=>"Medial", "relevance"=>"HIGH"}, {"id"=>"M12476", "name"=>"Niacinamide", "relevance"=>"LOW"}, {"id"=>"M12465", "name"=>"Niacin", "asFound"=>"Laser therapy", "relevance"=>"HIGH"}, {"id"=>"M12479", "name"=>"Nicotinic Acids", "relevance"=>"LOW"}, {"id"=>"M6226", "name"=>"Clofibrate", "asFound"=>"Gymnema Sylvestre", "relevance"=>"HIGH"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M4278", "name"=>"Hypolipidemic Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M28883", "name"=>"Lipid Regulating Agents", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"M4243", "name"=>"Anticholesteremic Agents", "relevance"=>"LOW"}, {"id"=>"T455", "name"=>"Nicotinamide", "relevance"=>"LOW"}, {"id"=>"T453", "name"=>"Niacin", "asFound"=>"Laser therapy", "relevance"=>"HIGH"}, {"id"=>"T454", "name"=>"Niacinamide", "relevance"=>"LOW"}, {"id"=>"T456", "name"=>"Nicotinic Acid", "relevance"=>"LOW"}, {"id"=>"T471", "name"=>"Vitamin B3", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Lipid Regulating Agents", "abbrev"=>"Lipd"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"PREVENTION"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1965-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-07", "completionDateStruct"=>{"date"=>"1985-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-11-25", "studyFirstSubmitDate"=>"1999-10-27", "studyFirstSubmitQcDate"=>"1999-10-27", "lastUpdatePostDateStruct"=>{"date"=>"2013-11-26", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-10-28", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Cardiovascular Diseases", "Coronary Disease", "Heart Diseases", "Myocardial Infarction", "Myocardial Ischemia"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967."}, {"type"=>"BACKGROUND", "citation"=>"Parsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6."}, {"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project, Publication l695. National Heart Institute, Public Health Service, l968."}, {"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group: Control of Hyperlipidemia: 4. Progress in Drug Trials of Secondary Prevention with Particular Reference to the Coronary Drug Project, in Jones, R.J. (ed), Atherosclerosis (Proceedings of the Second International Symposium). New York, Springer-Verlag, l970, pp. 586-595."}, {"pmid"=>"4320008", "type"=>"BACKGROUND", "citation"=>"The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA. 1970 Nov 16;214(7):1303-13. No abstract available."}, {"type"=>"BACKGROUND", "citation"=>"Heart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970."}, {"pmid"=>"4337170", "type"=>"BACKGROUND", "citation"=>"The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group. JAMA. 1972 May 15;220(7):996-1008. No abstract available."}, {"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group: The Natural History of Myocardial Infarction in the Coronary Drug Project: Prognostic Indicators Following Infarction, in Tibblin, G., Keys, A., Werko, L. (eds), Preventive Cardiology, Stockholm, Almqvist & Wiksell, l972, pp. 54-64."}, {"pmid"=>"4117098", "type"=>"BACKGROUND", "citation"=>"The prognostic importance of the electrocardiogram after myocardial infarction. Experience in the Coronary Drug Project. Ann Intern Med. 1972 Nov;77(5):677-89. doi: 10.7326/0003-4819-77-5-677. No abstract available."}, {"pmid"=>"4570454", "type"=>"BACKGROUND", "citation"=>"The coronary drug project. Design, methods, and baseline results. Circulation. 1973 Mar;47(3 Suppl):I1-50. doi: 10.1161/01.cir.47.3s1.i-1. No abstract available."}, {"pmid"=>"4119817", "type"=>"BACKGROUND", "citation"=>"Prognostic importance of premature beats following myocardial infarction. Experience in the coronary drug project. JAMA. 1973 Mar 5;223(10):1116-24. doi: 10.1001/jama.1973.03220100016005. No abstract available."}, {"pmid"=>"4356847", "type"=>"BACKGROUND", "citation"=>"The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group. JAMA. 1973 Nov 5;226(6):652-7. No abstract available."}, {"pmid"=>"4275188", "type"=>"BACKGROUND", "citation"=>"Left ventricular hypertrophy patterns and prognosis. Experience postinfarction in the Coronary Drug Project. Circulation. 1974 May;49(5):862-9. doi: 10.1161/01.cir.49.5.862. No abstract available."}, {"pmid"=>"4610000", "type"=>"BACKGROUND", "citation"=>"Factors influencing long-term prognosis after recovery from myocardial infarction--three-year findings of the coronary drug project. J Chronic Dis. 1974 Aug;27(6):267-85. doi: 10.1016/0021-9681(74)90091-5. No abstract available."}, {"pmid"=>"4138758", "type"=>"BACKGROUND", "citation"=>"The prognostic importance of premature ventricular complexes in the late post-infarction period. Experience in the Cornary Drug Project. Acta Cardiol. 1974;Suppl 18:33-53. No abstract available."}, {"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group: The Coronary Drug Project: A Secondary Prevention Trial, in Schettler, G. and Weizel, A. (eds), Atherosclerosis III. Berlin/New York, Springer-Verlag, l974, pp. 729-747."}, {"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group: Some Methodology for Relating Serial Observations to Mortality in Men with Coronary Heart Disease (Abstract). Am J Epidemiol, l00:529, l974."}, {"pmid"=>"1088963", "type"=>"BACKGROUND", "citation"=>"Clofibrate and niacin in coronary heart disease. JAMA. 1975 Jan 27;231(4):360-81. No abstract available."}, {"type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group: Reply to Letter to the Editor from D.J. Gans. JAMA, 234:22-23, l975."}, {"pmid"=>"956335", "type"=>"BACKGROUND", "citation"=>"Serum uric acid: its association with other risk factors and with mortality in coronary heart disease. J Chronic Dis. 1976 Sep;29(9):557-69. doi: 10.1016/0021-9681(76)90003-5. No abstract available."}, {"pmid"=>"789390", "type"=>"BACKGROUND", "citation"=>"Aspirin in coronary heart disease. The Coronary Drug Project Research Group. J Chronic Dis. 1976 Oct;29(10):625-42."}, {"pmid"=>"323090", "type"=>"BACKGROUND", "citation"=>"The prognostic importance of plasma glucose levels and of the use of oral hypoglycemic drugs after myocardial infarction in men. Diabetes. 1977 May;26(5):453-65."}, {"pmid"=>"195293", "type"=>"BACKGROUND", "citation"=>"Wenger NK, Stamler J. The Coronary Drug Project: implications for clinical care. Prim Care. 1977 Jun;4(2):247-53. No abstract available."}, {"pmid"=>"323705", "type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group. Gallbladder disease as a side effect of drugs influencing lipid metabolism. Experience in the Coronary Drug Project. N Engl J Med. 1977 May 26;296(21):1185-90. doi: 10.1056/NEJM197705262962101."}, {"pmid"=>"349581", "type"=>"BACKGROUND", "citation"=>"The coronary drug project aspirin study. Implications for clinical care. Coronary Drug Project Research Group. Prim Care. 1978 Mar;5(1):91-5. No abstract available."}, {"pmid"=>"356579", "type"=>"BACKGROUND", "citation"=>"Natural history of myocardial infarction in the coronary drug project: long-term prognostic importance of serum lipid levels. Coronary Drug Project Research Group. Am J Cardiol. 1978 Sep;42(3):489-98. doi: 10.1016/0002-9149(78)90946-3."}, {"pmid"=>"457827", "type"=>"BACKGROUND", "citation"=>"Cigarette smoking as a risk factor in men with a prior history of myocardial infarction. The Coronary Drug Project Research Group. J Chronic Dis. 1979;32(6):415-25. doi: 10.1016/0021-9681(79)90102-4. No abstract available."}, {"pmid"=>"6999345", "type"=>"BACKGROUND", "citation"=>"Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. N Engl J Med. 1980 Oct 30;303(18):1038-41. doi: 10.1056/NEJM198010303031804."}, {"pmid"=>"7002353", "type"=>"BACKGROUND", "citation"=>"Aspirin in coronary heart disease. The Coronary Drug Project Research Group. Circulation. 1980 Dec;62(6 Pt 2):V59-62."}, {"pmid"=>"7014029", "type"=>"BACKGROUND", "citation"=>"Canner PL, Halperin M. Implications of findings in the coronary drug project for secondary prevention trials in coronary heart disease. The coronary; drug project research group. Circulation. 1981 Jun;63(6):1342-50. doi: 10.1161/01.cir.63.6.1342. No abstract available."}, {"pmid"=>"7261627", "type"=>"BACKGROUND", "citation"=>"Practical aspects of decision making in clinical trials: the coronary drug project as a case study. The Coronary Drug Project Research Group. Control Clin Trials. 1981 May;1(4):363-76. doi: 10.1016/0197-2456(81)90041-6."}, {"pmid"=>"7094247", "type"=>"BACKGROUND", "citation"=>"Schlant RC, Forman S, Stamler J, Canner PL. The natural history of coronary heart disease: prognostic factors after recovery from myocardial infarction in 2789 men. The 5-year findings of the coronary drug project. Circulation. 1982 Aug;66(2):401-14. doi: 10.1161/01.cir.66.2.401. No abstract available."}, {"pmid"=>"6501718", "type"=>"BACKGROUND", "citation"=>"Blood pressure in survivors of myocardial infarction. The Coronary Drug Project Research Group. J Am Coll Cardiol. 1984 Dec;4(6):1135-47. doi: 10.1016/s0735-1097(84)80132-1."}, {"pmid"=>"29506561", "type"=>"DERIVED", "citation"=>"Murray EJ, Hernan MA. Improved adherence adjustment in the Coronary Drug Project. Trials. 2018 Mar 5;19(1):158. doi: 10.1186/s13063-018-2519-5."}]}, "descriptionModule"=>{"briefSummary"=>"To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.", "detailedDescription"=>"BACKGROUND:\n\nCorrelation of high levels of serum cholesterol with an increased incidence and prevalence of coronary heart disease (CHD) was demonstrated--prior to the inception of the Coronary Drug Project--repeatedly in prospective and cross-sectional epidemiological surveys (e.g., the Tecumseh Study, the Framingham Heart Disease Study). These findings led to the question of whether long-term lowering of serum lipids in individuals both with and without CHD would have a beneficial effect on morbidity and mortality.\n\nThe Coronary Drug Project was designed to answer the question of secondary prevention. In 1961, Dr. Robert Wilkins (Boston University School of Medicine) chaired an ad hoc committee which determined the desirability and feasibility of the conduct of this study. Following National Heart Advisory Council (NHAC) support, a study Policy Board, Steering Committee, and Coordinating Center were established and a detailed protocol was written.\n\nIn 1964, NHAC approved the project and the NHI recommendation for implementation; the study was begun in 1965. Supported by the grant mechanism, the trial involved 53 participating clinics, a coordinating center, central laboratory, ECG center, drug procurement and distribution center, and NHI medical liaison office, and a policy board, steering committee, and 12 other committees (e.g., a data and safety monitoring committee).\n\nThe first patient was randomly allocated to treatment in March 1966 and the last in October 1969. Each patient reported to the clinic every 4 months for a follow-up visit.\n\nDESIGN NARRATIVE:\n\nRandomized, double-blind, fixed sample. A total of 8,341 patients were randomly assigned to six treatment groups consisting of 2.5 mg/day of conjugated estrogens, 5.0 mg/day of conjugated estrogens, 1.8 gm/day of clofibrate, 6.0 mg/day of dextrothyroxine sodium, 3.0 gm/day of niacin, or 3.8 gm/day of lactose placebo.\n\nThe study completion date listed in this record was obtained from the Query/View/Report (QVR) System."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"64 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Men, ages 30-64. Three months beyond most recent myocardial infarction."}, "identificationModule"=>{"nctId"=>"NCT00000482", "briefTitle"=>"Coronary Drug Project", "organization"=>{"class"=>"NIH", "fullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "orgStudyIdInfo"=>{"id"=>"1"}, "secondaryIdInfos"=>[{"id"=>"R01HL008888-14", "type"=>"OTHER_GRANT", "domain"=>"US NIH Grant Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"estrogen", "type"=>"DRUG"}, {"name"=>"clofibrate clofibrate", "type"=>"DRUG"}, {"name"=>"dextrothyroxine sodium", "type"=>"DRUG"}, {"name"=>"niacin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Paul Canner", "affiliation"=>"University of Maryland"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
