NCT00000472

Brief Summary

The Thrombolysis in Myocardial Ischemia Trial (TIMI III) focused on unstable angina and non-Q-wave myocardial infarction. The trial was designed to determine by coronary arteriography the incidence of coronary thrombi in these conditions and the response of these thrombi to tissue-type plasminogen activator (t-PA) in TIMI IIIA and the effects of thrombolytic therapy and of an early invasive strategy on clinical outcome in TIMI IIIB. There was also a registry with two components. A roster enumerated all patients with unstable angina or non-Q-wave myocardial infarction enrolled at cooperating hospitals. From the roster, a study population of 1,893 subjects was selected and followed prospectively for the year to determine incidence of death or myocardial infarction.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1989

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1989

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1995

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

March 16, 2016

Status Verified

July 1, 2000

First QC Date

October 27, 1999

Last Update Submit

March 15, 2016

Conditions

Interventions

Eligibility Criteria

Age21 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, ages 21 to 76, with unstable angina or non-Q-wave myocardial infarction.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (18)

  • Williams DO, Braunwald E, Thompson B, Sharaf BL, Buller CE, Knatterud GL. Results of percutaneous transluminal coronary angioplasty in unstable angina and non-Q-wave myocardial infarction. Observations from the TIMI IIIB Trial. Circulation. 1996 Dec 1;94(11):2749-55. doi: 10.1161/01.cir.94.11.2749.

    PMID: 8941099BACKGROUND
  • Early effects of tissue-type plasminogen activator added to conventional therapy on the culprit coronary lesion in patients presenting with ischemic cardiac pain at rest. Results of the Thrombolysis in Myocardial Ischemia (TIMI IIIA) Trial. Circulation. 1993 Jan;87(1):38-52. doi: 10.1161/01.cir.87.1.38.

    PMID: 8419023BACKGROUND
  • Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non-Q-wave myocardial infarction. Results of the TIMI IIIB Trial. Thrombolysis in Myocardial Ischemia. Circulation. 1994 Apr;89(4):1545-56. doi: 10.1161/01.cir.89.4.1545.

    PMID: 8149520BACKGROUND
  • Diver DJ, Bier JD, Ferreira PE, Sharaf BL, McCabe C, Thompson B, Chaitman B, Williams DO, Braunwald E. Clinical and arteriographic characterization of patients with unstable angina without critical coronary arterial narrowing (from the TIMI-IIIA Trial). Am J Cardiol. 1994 Sep 15;74(6):531-7. doi: 10.1016/0002-9149(94)90739-0.

    PMID: 8074033BACKGROUND
  • Cannon CP, Thompson B, McCabe CH, Mueller HS, Kirshenbaum JM, Herson S, Nasmith JB, Chaitman BR, Braunwald E. Predictors of non-Q-wave acute myocardial infarction in patients with acute ischemic syndromes: an analysis from the Thrombolysis in Myocardial Ischemia (TIMI) III trials. Am J Cardiol. 1995 May 15;75(15):977-81. doi: 10.1016/s0002-9149(99)80707-3.

    PMID: 7747698BACKGROUND
  • Anderson HV, Cannon CP, Stone PH, Williams DO, McCabe CH, Knatterud GL, Thompson B, Willerson JT, Braunwald E. One-year results of the Thrombolysis in Myocardial Infarction (TIMI) IIIB clinical trial. A randomized comparison of tissue-type plasminogen activator versus placebo and early invasive versus early conservative strategies in unstable angina and non-Q wave myocardial infarction. J Am Coll Cardiol. 1995 Dec;26(7):1643-50. doi: 10.1016/0735-1097(95)00404-1.

    PMID: 7594098BACKGROUND
  • Becker RC, Cannon CP, Tracy RP, Thompson B, Bovill EG, Desvigne-Nickens P, Randall AM, Knatternud G, Braunwald E. Relation between systemic anticoagulation as determined by activated partial thromboplastin time and heparin measurements and in-hospital clinical events in unstable angina and non-Q wave myocardiaL infarction. Thrombolysis in Myocardial Ischemia III B Investigators. Am Heart J. 1996 Mar;131(3):421-33. doi: 10.1016/s0002-8703(96)90519-0.

    PMID: 8604620BACKGROUND
  • Stone PH, Thompson B, Anderson HV, Kronenberg MW, Gibson RS, Rogers WJ, Diver DJ, Theroux P, Warnica JW, Nasmith JB, Kells C, Kleiman N, McCabe CH, Schactman M, Knatterud GL, Braunwald E. Influence of race, sex, and age on management of unstable angina and non-Q-wave myocardial infarction: The TIMI III registry. JAMA. 1996 Apr 10;275(14):1104-12.

    PMID: 8601930BACKGROUND
  • Kleiman NS, Anderson HV, Rogers WJ, Theroux P, Thompson B, Stone PH. Comparison of outcome of patients with unstable angina and non-Q-wave acute myocardial infarction with and without prior coronary artery bypass grafting (Thrombolysis in Myocardial Ischemia III Registry). Am J Cardiol. 1996 Feb 1;77(4):227-31. doi: 10.1016/s0002-9149(97)89383-6.

    PMID: 8607398BACKGROUND
  • Becker RC, Cannon CP, Bovill EG, Tracy RP, Thompson B, Knatterud GL, Randall A, Braunwald B. Prognostic value of plasma fibrinogen concentration in patients with unstable angina and non-Q-wave myocardial infarction (TIMI IIIB Trial). Am J Cardiol. 1996 Jul 15;78(2):142-7. doi: 10.1016/s0002-9149(96)90386-0.

    PMID: 8712133BACKGROUND
  • Cannon CP, McCabe CH, Stone PH, Schactman M, Thompson B, Theroux P, Gibson RS, Feldman T, Kleiman NS, Tofler GH, Muller JE, Chaitman BR, Braunwald E. Circadian variation in the onset of unstable angina and non-Q-wave acute myocardial infarction (the TIMI III Registry and TIMI IIIB). Am J Cardiol. 1997 Feb 1;79(3):253-8. doi: 10.1016/s0002-9149(97)00743-1.

    PMID: 9036740BACKGROUND
  • Bovill EG, Tracy RP, Knatterud GL, Stone PH, Nasmith J, Gore JM, Thompson BW, Tofler GH, Kleiman NS, Cannon C, Braunwald E. Hemorrhagic events during therapy with recombinant tissue plasminogen activator, heparin, and aspirin for unstable angina (Thrombolysis in Myocardial Ischemia, phase IIIB trial). Am J Cardiol. 1997 Feb 15;79(4):391-6. doi: 10.1016/s0002-9149(96)00773-4.

    PMID: 9052337BACKGROUND
  • Cannon CP, McCabe CH, Stone PH, Rogers WJ, Schactman M, Thompson BW, Pearce DJ, Diver DJ, Kells C, Feldman T, Williams M, Gibson RS, Kronenberg MW, Ganz LI, Anderson HV, Braunwald E. The electrocardiogram predicts one-year outcome of patients with unstable angina and non-Q wave myocardial infarction: results of the TIMI III Registry ECG Ancillary Study. Thrombolysis in Myocardial Ischemia. J Am Coll Cardiol. 1997 Jul;30(1):133-40. doi: 10.1016/s0735-1097(97)00160-5.

    PMID: 9207634BACKGROUND
  • Hochman JS, McCabe CH, Stone PH, Becker RC, Cannon CP, DeFeo-Fraulini T, Thompson B, Steingart R, Knatterud G, Braunwald E. Outcome and profile of women and men presenting with acute coronary syndromes: a report from TIMI IIIB. TIMI Investigators. Thrombolysis in Myocardial Infarction. J Am Coll Cardiol. 1997 Jul;30(1):141-8. doi: 10.1016/s0735-1097(97)00107-1.

    PMID: 9207635BACKGROUND
  • Anderson HV, Gibson RS, Stone PH, Cannon CP, Aguirre F, Thompson B, Knatterud GL, Braunwald E. Management of unstable angina pectoris and non-Q-wave acute myocardial infarction in the United States and Canada (the TIMI III Registry). Am J Cardiol. 1997 Jun 1;79(11):1441-6. doi: 10.1016/s0002-9149(97)00168-9.

    PMID: 9185630BACKGROUND
  • Jain D, Thompson B, Wackers FJ, Zaret BL. Relevance of increased lung thallium uptake on stress imaging in patients with unstable angina and non-Q wave myocardial infarction: results of the Thrombolysis in Myocardial Infarction (TIMI)-IIIB Study. J Am Coll Cardiol. 1997 Aug;30(2):421-9. doi: 10.1016/s0735-1097(97)00164-2.

    PMID: 9247514BACKGROUND
  • Stone PH, Thompson B, Zaret BL, Chaitman B, Gibson RS, Schweiger MJ, Steingart R, Kirshenbaum J, Thompson C, Fung A, McCabe CH, Knatterud GL, Braunwald E. Factors associated with failure of medical therapy in patients with unstable angina and non-Q wave myocardial infarction. A TIMI-IIIB database study. Eur Heart J. 1999 Aug;20(15):1084-93. doi: 10.1053/euhj.1998.1480.

    PMID: 10413638BACKGROUND
  • Brewster LM, Fernand J. Creatine kinase during non-ST-segment elevation acute coronary syndromes is associated with major bleeding. Open Heart. 2020 Dec;7(2):e001281. doi: 10.1136/openhrt-2020-001281.

MeSH Terms

Conditions

Angina PectorisCardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial InfarctionMyocardial Ischemia

Interventions

Tissue Plasminogen ActivatorHeparin

Condition Hierarchy (Ancestors)

Vascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological FactorsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Eugene Braunwald

    Brigham and Women's Hospital

  • Kenneth Mann

    University of Vermont

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1989

Study Completion

June 1, 1995

Last Updated

March 16, 2016

Record last verified: 2000-07