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NCT00000505
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The TIMI Research Group. Am J Cardiol. 1993 May 15;71(13):1148-52. doi: 10.1016/0002-9149(93)90637-r."}, {"ReferencePMID"=>"8354803", "ReferenceType"=>"background", "ReferenceCitation"=>"Lehmann KG, Francis CK, Sheehan FH, Dodge HT. Effect of thrombolysis on acute mitral regurgitation during evolving myocardial infarction. Experience from the Thrombolysis in Myocardial Infarction (TIMI) Trial. J Am Coll Cardiol. 1993 Sep;22(3):714-9. doi: 10.1016/0735-1097(93)90181-y."}, {"ReferencePMID"=>"8023772", "ReferenceType"=>"background", "ReferenceCitation"=>"Schweiger MJ, McMahon RP, Terrin ML, Ruocco NA, Porway MN, Wiseman AH, Knatterud GL, Braunwald E. Comparison of patients with < 60% to > or = 60% diameter narrowing of the myocardial infarct-related artery after thrombolysis. The TIMI Investigators. Am J Cardiol. 1994 Jul 15;74(2):105-10. doi: 10.1016/0002-9149(94)90081-7."}, {"ReferencePMID"=>"8135447", "ReferenceType"=>"background", "ReferenceCitation"=>"Becker RC, Terrin M, Ross R, Knatterud GL, Desvigne-Nickens P, Gore JM, Braunwald E. Comparison of clinical outcomes for women and men after acute myocardial infarction. The Thrombolysis in Myocardial Infarction Investigators. Ann Intern Med. 1994 Apr 15;120(8):638-45. doi: 10.7326/0003-4819-120-8-199404150-00003."}, {"ReferencePMID"=>"8026055", "ReferenceType"=>"background", "ReferenceCitation"=>"Aguirre FV, McMahon RP, Mueller H, Kleiman NS, Kern MJ, Desvigne-Nickens P, Hamilton WP, Chaitman BR. Impact of age on clinical outcome and postlytic management strategies in patients treated with intravenous thrombolytic therapy. Results from the TIMI II Study. TIMI II Investigators. Circulation. 1994 Jul;90(1):78-86. doi: 10.1161/01.cir.90.1.78."}, {"ReferencePMID"=>"8160607", "ReferenceType"=>"background", "ReferenceCitation"=>"Cox DA, Rogers WJ, Aguirre FV, Forman S, Solomon R, Zaret BL. Effect on outcome of the presence or absence of chest pain at initiation of recombinant tissue plasminogen activator therapy in acute myocardial infarction. The Thrombolysis in Myocardial Infarction Investigators. Am J Cardiol. 1994 Apr 15;73(11):729-36. doi: 10.1016/0002-9149(94)90872-9."}, {"ReferencePMID"=>"7829793", "ReferenceType"=>"background", "ReferenceCitation"=>"Gersh BJ, Chesebro JH, Braunwald E, Lambrew C, Passamani E, Solomon RE, Ross AM, Ross R, Terrin ML, Knatterud GL. Coronary artery bypass graft surgery after thrombolytic therapy in the Thrombolysis in Myocardial Infarction Trial, Phase II (TIMI II). J Am Coll Cardiol. 1995 Feb;25(2):395-402. doi: 10.1016/0735-1097(94)00387-6."}, {"ReferencePMID"=>"7797778", "ReferenceType"=>"background", "ReferenceCitation"=>"Zaret BL, Wackers FJ, Terrin ML, Forman SA, Williams DO, Knatterud GL, Braunwald E. Value of radionuclide rest and exercise left ventricular ejection fraction in assessing survival of patients after thrombolytic therapy for acute myocardial infarction: results of Thrombolysis in Myocardial Infarction (TIMI) phase II study. The TIMI Study Group. J Am Coll Cardiol. 1995 Jul;26(1):73-9. doi: 10.1016/0735-1097(95)00146-q."}, {"ReferencePMID"=>"7594070", "ReferenceType"=>"background", "ReferenceCitation"=>"Hall C, Cannon CP, Forman S, Braunwald E. Prognostic value of N-terminal proatrial natriuretic factor plasma levels measured within the first 12 hours after myocardial infarction. Thrombolysis in Myocardial Infarction (TIMI) II Investigators. J Am Coll Cardiol. 1995 Nov 15;26(6):1452-6. doi: 10.1016/0735-1097(95)00342-8."}, {"ReferencePMID"=>"8521582", "ReferenceType"=>"background", "ReferenceCitation"=>"Simon K, Szepvolgyi A. Early and 1-year clinical outcome of patients evolving non-Q-wave versus Q-wave myocardial infarction after thrombolysis: results from the TIMI II study. Circulation. 1995 Dec 15;92(12):3575-6. No abstract available."}, {"ReferencePMID"=>"7560615", "ReferenceType"=>"background", "ReferenceCitation"=>"Mueller HS, Forman SA, Menegus MA, Cohen LS, Knatterud GL, Braunwald E. Prognostic significance of nonfatal reinfarction during 3-year follow-up: results of the Thrombolysis in Myocardial Infarction (TIMI) phase II clinical trial. The TIMI Investigators. J Am Coll Cardiol. 1995 Oct;26(4):900-7. doi: 10.1016/0735-1097(95)00270-1."}, {"ReferencePMID"=>"7743615", "ReferenceType"=>"background", "ReferenceCitation"=>"Aguirre FV, Younis LT, Chaitman BR, Ross AM, McMahon RP, Kern MJ, Berger PB, Sopko G, Rogers WJ, Shaw L, et al. Early and 1-year clinical outcome of patients' evolving non-Q-wave versus Q-wave myocardial infarction after thrombolysis. Results from The TIMI II Study. Circulation. 1995 May 15;91(10):2541-8. doi: 10.1161/01.cir.91.10.2541."}, {"ReferencePMID"=>"7723950", "ReferenceType"=>"background", "ReferenceCitation"=>"Sloan MA, Price TR, Petito CK, Randall AM, Solomon RE, Terrin ML, Gore J, Collen D, Kleiman N, Feit F, et al. Clinical features and pathogenesis of intracerebral hemorrhage after rt-PA and heparin therapy for acute myocardial infarction: the Thrombolysis in Myocardial Infarction (TIMI) II Pilot and Randomized Clinical Trial combined experience. Neurology. 1995 Apr;45(4):649-58. doi: 10.1212/wnl.45.4.649."}, {"ReferencePMID"=>"9453518", "ReferenceType"=>"background", "ReferenceCitation"=>"Tracy RP, Kleiman NS, Thompson B, Cannon CP, Bovill EG, Brown RG, Collen D, Mahan E, Mann KG, Rogers WJ, Sopko G, Stump DC, Williams DO, Zaret BL. Relation of coagulation parameters to patency and recurrent ischemia in the Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial. Am Heart J. 1998 Jan;135(1):29-37. doi: 10.1016/s0002-8703(98)70339-4."}, {"ReferencePMID"=>"3309009", "ReferenceType"=>"background", "ReferenceCitation"=>"Braunwald E, Knatterud GL, Passamani E, Robertson TL, Solomon R. Update from the Thrombolysis in Myocardial Infarction Trial. J Am Coll Cardiol. 1987 Oct;10(4):970. doi: 10.1016/s0735-1097(87)80296-6. No abstract available."}, {"ReferencePMID"=>"2959484", "ReferenceType"=>"background", "ReferenceCitation"=>"Robertson TL. Myocardial infarction: systemic thrombolysis in the U.S.A. Eur Heart J. 1987 Sep;8 Suppl F:67-71. doi: 10.1093/eurheartj/8.suppl_f.67. No abstract available."}, {"ReferencePMID"=>"1596042", "ReferenceType"=>"background", "ReferenceCitation"=>"Lehmann KG, Francis CK, Dodge HT. Mitral regurgitation in early myocardial infarction. Incidence, clinical detection, and prognostic implications. TIMI Study Group. Ann Intern Med. 1992 Jul 1;117(1):10-7. doi: 10.7326/0003-4819-117-1-10. Erratum In: Ann Intern Med 1992 Aug 15;117(4):349."}]}}, "DescriptionModule"=>{"BriefSummary"=>"In TIMI I, to assess the relative thrombolytic activity and side effects of intravenous recombinant tissue-type plasminogen activator (rt-PA) versus intravenous streptokinase in patients with acute myocardial infarction. In TIMI II, to assess whether intravenous rt-PA given in the early hours of acute myocardial infarction should be followed by percutaneous transluminal coronary angioplasty (PTCA).", "DetailedDescription"=>"BACKGROUND:\n\nCoronary artery disease is the leading cause of death in the United States, accounting for almost 500,000 deaths each year. Studies have confirmed that myocardial infarction is related to an occlusive coronary thrombus in up to 80 percent of patients. First and second-generation thrombolytic agents (including streptokinase and rt-PA) have been successfully used to restore myocardial blood flow where thrombus has occluded an infarct-related coronary artery. However, further clinical investigation was necessary to determine the most suitable thrombolytic agent dose and method of administration, the risk of subsequent reocclusion, restenosis, and/or myocardial infarction, the need for additional therapies, and the likelihood of benefit or hemorrhagic complications.\n\nIn 1983 the National Heart, Lung, and Blood Institute established the TIMI Study Group. The group consisted of 13 clinical centers (later expanded to 24), a Radiographic Core Laboratory, Radionuclide Core Laboratory, and a Data Coordinating Center.\n\nDESIGN NARRATIVE:\n\nThe TIMI trial was conducted in two stages. In Phase I or TIMI I, eligible patients were randomized to receive either 80 mg of recombinant tissue-type plasminogen activator (rt-PA) or 1.5 million units of streptokinase intravenously to determine relative safety and efficacy. Following randomization, patients found to have angiographically documented stenosis greater than 50 percent in the infarct-related artery received thrombolytic therapy in a double-blind fashion, full anticoagulation, and conventional care. Patients subsequently underwent repeat catheterization, radionuclide ventriculogram, and pre-discharge, six-week and six-month cardiovascular examination.\n\nTIMI I was stopped in February 1985 because of statistically significant differences in coronary reperfusion rates in the treatment groups; rt-PA was found to be the superior thrombolytic agent. Following TIMI Phase I, the manufacturer of rt-PA changed to a large-scale production method for rt-PA, and the new product was found to have thrombolytic activity and specificity in vitro and in experimental animals comparable to the product manufactured by the old method. However, the TIMI investigators concluded that clinical evaluation would be necessary prior to initiation of TIMI Phase II.\n\nThus, TIMI Open Label Phase studies were initiated in 1985, with the aim of establishing the safety and efficacy of the 'new' intravenous rt-PA. As in Phase I, the endpoint was lysis of coronary thrombus within 90 minutes of the initiation of treatment in patients with documented total occlusion of the infarct-related coronary artery. Additional goals of the study were to determine reocclusion rates of infarct-related arteries at 18-48 hours, as well as to determine the efficacy of PTCA to maintain perfusion in infarct-related arteries and prevention of recurrent myocardial infarction. The TIMI Open Label Phase studies determined that optimal coronary recanalization and maintenance of reperfusion occurred with 150 mg of 'new' rt-PA infused over six hours. However, subsequent hemorrhagic complications observed with 150 mg rt-PA necessitated a change in the dose of rt-PA to 100 mg.\n\nIn TIMI II, patient entry began in April 1986 and ended in June 1988 with enrollment of 3,534 patients. Patients were treated with intravenous rt-PA within four hours of the onset of chest pain thought to be caused by myocardial infarction and randomly assigned to an invasive strategy or a conservative strategy. The primary endpoint was survival free of recurrent myocardial infarction at six weeks and one year of follow-up. There were 1,681 patients assigned to the delayed invasive strategy in which catheterization was performed between 18 and 48 hours after rt-PA therapy. If catheterization showed a greater than 60 percent subtotal stenosis of the infarct-related artery that was considered to be technically approachable, angioplasty was attempted. Angioplasty was performed in 60.5 percent of the 1,500 patients who underwent catheterization in the invasive strategy group. The remaining 39.5 percent or 593 patients did not have angioplasty performed. There were 1,658 patients assigned to a conservative strategy in which cardiac catheterization was reserved for the 587 patients who had spontaneous or exercise-induced myocardial ischemia within 21 days of infarction. A total of 13.5 percent of patients in this arm underwent coronary angioplasty, 7.6 percent underwent bypass surgery, and 1.1 percent underwent both procedures; 77 percent of the patients in the conservative strategy group had no revascularization procedure within 21 days of infarction.\n\nTIMI IIA, a subtrial of 586 patients, investigated whether immediate cardiac catheterization with percutaneous transluminal coronary angioplasty, when appropriate, would confer an advantage over the same procedure performed 18 to 48 hours later. All patients were treated with intravenous rt-PA within four hours of the onset of acute myocardial infarction.\n\nThe study completion date listed in this record was obtained from the \"End Date\" entered in the Protocol Registration and Results System (PRS) record."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"75 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Men and women under age 76. Patients had acute myocardial infarction."}, "IdentificationModule"=>{"NCTId"=>"NCT00000505", "BriefTitle"=>"Thrombolysis in Myocardial Infarction (TIMI)", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"24"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01HL042311", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL042311", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"tissue plasminogen activator", "InterventionType"=>"Drug"}, {"InterventionName"=>"angioplasty, transluminal, percutaneous coronary", "InterventionType"=>"Procedure"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Joseph Babb", "OverallOfficialAffiliation"=>"Bridgeport Hospital"}, {"OverallOfficialName"=>"Jeffery Borer", "OverallOfficialAffiliation"=>"Weill Medical College of Cornell University"}, {"OverallOfficialName"=>"Bernard Chaitman", "OverallOfficialAffiliation"=>"St. Louis University Medical Center"}, {"OverallOfficialName"=>"James Chesebro", "OverallOfficialAffiliation"=>"Mayo Foundation"}, {"OverallOfficialName"=>"Richard Davison", "OverallOfficialAffiliation"=>"Northwestern University"}, {"OverallOfficialName"=>"Harold Dodge", "OverallOfficialAffiliation"=>"University of Washington"}, {"OverallOfficialName"=>"Frederick Feit", "OverallOfficialAffiliation"=>"NYU Langone Health"}, {"OverallOfficialName"=>"Charles Francis", "OverallOfficialAffiliation"=>"Yale University"}, {"OverallOfficialName"=>"Joel Gore", "OverallOfficialAffiliation"=>"University of Massachusetts, Worcester"}, {"OverallOfficialName"=>"Michael Herman", "OverallOfficialAffiliation"=>"New York Medical College"}, {"OverallOfficialName"=>"Morrison Hodges", "OverallOfficialAffiliation"=>"University of Minnesota"}, {"OverallOfficialName"=>"Harvey Kemp", "OverallOfficialAffiliation"=>"St. Luke's-Roosevelt Institute for Health Sciences"}, {"OverallOfficialName"=>"Genell Knatterud", "OverallOfficialAffiliation"=>"Maryland Medical Research Institute"}, {"OverallOfficialName"=>"Costas Lambrew", "OverallOfficialAffiliation"=>"MaineHealth"}, {"OverallOfficialName"=>"Philip Ludbrook", "OverallOfficialAffiliation"=>"Washington University School of Medicine"}, {"OverallOfficialName"=>"Kenneth Mann", "OverallOfficialAffiliation"=>"University of Vermont"}, {"OverallOfficialName"=>"John Markis", "OverallOfficialAffiliation"=>"Beth Israel Hospital"}, {"OverallOfficialName"=>"John Morrison", "OverallOfficialAffiliation"=>"North Shore University Hospital"}, {"OverallOfficialName"=>"Hiltrud Mueller", "OverallOfficialAffiliation"=>"Montefiore Medical Center"}, {"OverallOfficialName"=>"Eric Powers", "OverallOfficialAffiliation"=>"Columbia University"}, {"OverallOfficialName"=>"Robert Roberts", "OverallOfficialAffiliation"=>"Baylor College of Medicine"}, {"OverallOfficialName"=>"Williams Rogers", "OverallOfficialAffiliation"=>"University of Alabama at Birmingham"}, {"OverallOfficialName"=>"Allan Ross", "OverallOfficialAffiliation"=>"George Washington University"}, {"OverallOfficialName"=>"Thomas Ryan", "OverallOfficialAffiliation"=>"University Hospital Inc."}, {"OverallOfficialName"=>"Marc Schweiger", "OverallOfficialAffiliation"=>"Baystate Medical Center"}, {"OverallOfficialName"=>"Gerald Timmis", "OverallOfficialAffiliation"=>"William Beaumont Hospitals"}, {"OverallOfficialName"=>"James Willerson", "OverallOfficialAffiliation"=>"University of Texas"}, {"OverallOfficialName"=>"David Williams", "OverallOfficialAffiliation"=>"Rhode Island Hospital"}, {"OverallOfficialName"=>"Barry Zaret", "OverallOfficialAffiliation"=>"Yale University"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
