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Volume 333:1581-1588 December 14, 1995 Number 24 Next

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ABSTRACT

Background Thrombolytic therapy for acute ischemic stroke has been approached cautiously because there were high rates of intracerebral hemorrhage in early clinical trials. We performed a randomized, double-blind trial of intravenous recombinant tissue plasminogen activator (t-PA) for ischemic stroke after recent pilot studies suggested that t-PA was beneficial when treatment was begun within three hours of the onset of stroke.

Methods The trial had two parts. Part 1 (in which 291 patients were enrolled) tested whether t-PA had clinical activity, as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale (NIHSS) or the resolution of the neurologic deficit within 24 hours of the onset of stroke. Part 2 (in which 333 patients were enrolled) used a global test statistic to assess clinical outcome at three months, according to scores on the Barthel index, modified Rankin scale, Glasgow outcome scale, and NIHSS.

Results In part 1, there was no significant difference between the group given t-PA and that given placebo in the percentages of patients with neurologic improvement at 24 hours, although a benefit was observed for the t-PA group at three months for all four outcome measures. In part 2, the long-term clinical benefit of t-PA predicted by the results of part 1 was confirmed (global odds ratio for a favorable outcome, 1.7; 95 percent confidence interval, 1.2 to 2.6). As compared with patients given placebo, patients treated with t-PA were at least 30 percent more likely to have minimal or no disability at three months on the assessment scales. Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred in 6.4 percent of patients given t-PA but only 0.6 percent of patients given placebo (P<0.001). Mortality at three months was 17 percent in the t-PA group and 21 percent in the placebo group (P = 0.30).

Conclusions Despite an increased incidence of symptomatic intracerebral hemorrhage, treatment with intravenous t-PA within three hours of the onset of ischemic stroke improved clinical outcome at three months.

Source Information

Dr. John Marler, as project officer for the study, assumes full responsibility for the overall content and integrity of the manuscript.

Address reprint requests to Dr. John R. Marler at the Division of Stroke and Trauma, National Institute of Neurological Disorders and Stroke, Federal Bldg., Rm. 800, 7550 Wisconsin Ave., Bethesda, MD 20892.

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• Wasiewski, W. W. (2009). To Phase 3 or Not to Phase 3?. Stroke 40: 1553-1554 [Full Text]  
• Mayer, S. A., Schwab, S. (2009). Advances in Critical Care and Emergency Medicine. Stroke 40: e298-e300 [Full Text]  
• Meyers, P. M., Schumacher, H. C., Higashida, R. T., Barnwell, S. L., Creager, M. A., Gupta, R., McDougall, C. G., Pandey, D. K., Sacks, D., Wechsler, L. R. (2009). Indications for the Performance of Intracranial Endovascular Neurointerventional Procedures: A Scientific Statement From the American Heart Association Council on Cardiovascular Radiology and Intervention, Stroke Council, Council on Cardiovascular Surgery and Anesthesia, Interdisciplinary Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Circulation 119: 2235-2249 [Full Text]  
• Arsava, E. M., Rahman, R., Rosand, J., Lu, J., Smith, E. E., Rost, N. S., Singhal, A. B., Lev, M. H., Furie, K. L., Koroshetz, W. J., Sorensen, A. G., Ay, H. (2009). Severity of leukoaraiosis correlates with clinical outcome after ischemic stroke. Neurology 72: 1403-1410 [Abstract] [Full Text]  
• Saver, J. L., Gornbein, J. (2009). Treatment effects for which shift or binary analyses are advantageous in acute stroke trials. Neurology 72: 1310-1315 [Abstract] [Full Text]  
• Hommel, M, Trabucco-Miguel, S, Joray, S, Naegele, B, Gonnet, N, Jaillard, A (2009). Social dysfunctioning after mild to moderate first-ever stroke at vocational age. J. Neurol. Neurosurg. Psychiatry 80: 371-375 [Abstract] [Full Text]  
• Konstas, A.A., Goldmakher, G.V., Lee, T.-Y., Lev, M.H. (2009). Theoretic Basis and Technical Implementations of CT Perfusion in Acute Ischemic Stroke, Part 1: Theoretic Basis. Am. J. Neuroradiol. 30: 662-668 [Abstract] [Full Text]  
• Nogueira, R.G., Schwamm, L.H., Hirsch, J.A. (2009). Endovascular Approaches to Acute Stroke, Part 1: Drugs, Devices, and Data. Am. J. Neuroradiol. 30: 649-661 [Abstract] [Full Text]  
• Lansberg, M. G., Schwartz, N. E. (2009). Tissue Plasminogen Activator Does Not Benefit Most Eligible Patients With Stroke. Arch Neurol 66: 540-541 [Full Text]  
• Mateen, F. J., Nasser, M., Spencer, B. R., Freeman, W. D., Shuaib, A., Demaerschalk, B. M., Wijdicks, E. F. M. (2009). Outcomes of Intravenous Tissue Plasminogen Activator for Acute Ischemic Stroke in Patients Aged 90 Years or Older. Mayo Clin Proc. 84: 334-338 [Abstract] [Full Text]  
• Ford, A. L., Connor, L. T., Tan, D. K., Williams, J. A., Lee, J.-M., Nassief, A. M. (2009). Resident-Based Acute Stroke Protocol Is Expeditious and Safe. Stroke 40: 1512-1514 [Abstract] [Full Text]  
• Zivin, J. A., Albers, G. W., Bornstein, N., Chippendale, T., Dahlof, B., Devlin, T., Fisher, M., Hacke, W., Holt, W., Ilic, S., Kasner, S., Lew, R., Nash, M., Perez, J., Rymer, M., Schellinger, P., Schneider, D., Schwab, S., Veltkamp, R., Walker, M., Streeter, J., for the NEST-2 Investigators, (2009). Effectiveness and Safety of Transcranial Laser Therapy for Acute Ischemic Stroke. Stroke 40: 1359-1364 [Abstract] [Full Text]  
• Whitehead, J., Bolland, K., Valdes-Marquez, E., Lihic, A., Ali, M., Lees, K., for the VISTA Collaborators, (2009). Using Historical Lesion Volume Data in the Design of a New Phase II Clinical Trial in Acute Stroke. Stroke 40: 1347-1352 [Abstract] [Full Text]  
• Ebinger, M., Christensen, S., De Silva, D. A., Parsons, M. W., Levi, C. R., Butcher, K. S., Bladin, C. F., Barber, P. A., Donnan, G. A., Davis, S. M., for the EPITHET Investigators, (2009). Expediting MRI-Based Proof-of-Concept Stroke Trials Using an Earlier Imaging End Point. Stroke 40: 1353-1358 [Abstract] [Full Text]  
• Parsons, M. W., Miteff, F., Bateman, G. A., Spratt, N., Loiselle, A., Attia, J., Levi, C. R. (2009). Acute ischemic stroke: Imaging-guided tenecteplase treatment in an extended time window. Neurology 72: 915-921 [Abstract] [Full Text]  
• Shuaib, A. (2009). Disappearance of the hyperdense MCA sign after thrombolysis: is it a predictor of better prognosis in patients with acute ischaemic stroke?. J. Neurol. Neurosurg. Psychiatry 80: 248-248 [Full Text]  
• Cloft, H.J., Rabinstein, A., Lanzino, G., Kallmes, D.F. (2009). Intra-Arterial Stroke Therapy: An Assessment of Demand and Available Work Force. Am. J. Neuroradiol. 30: 453-458 [Abstract] [Full Text]  
• Ozdemir, O., Beletsky, V., Chan, R., Hachinski, V. (2009). Thrombolysis, Fluctuations, and Protocol Expansions--Reply. Arch Neurol 66: 418-419 [Full Text]