The rtPA (Alteplase) 0- to 6-hour acute stroke trial, part A (A0276g)

Results of a double-blind, placebo-controlled, multicenter study

Wayne Clark, Gregory W. Albers, Kenneth P. Madden, Scott Hamilton

Research output: Contribution to journalArticle

323 Citations (Scopus)

Abstract

Background and Purpose - The Thrombolytic Therapy in Acute Ischemic Stroke Study, which started in August of 1991, was designed to assess the efficacy and safety of intravenous rtPA (alteplase) in patients with acute (0 to 6 hours) ischemic stroke. In October 1993 enrollment was halted because of Safety Committee (DMSB) concerns. December 1993 the time window was changed to 0 to 5 hours, and it was decided to restart enrollment as a separate study (part B). We report here the results of the original study (part A), focusing on evaluating the safety and efficacy of rtPA given between 0 and 6 hours after stroke onset. Methods - This investigation was a phase II, placebo- controlled, double-blind, randomized study utilizing 0.9 mg/kg IV rtPA or placebo over 1 hour, which was conducted at university and community sites in North America. Except for time to treatment, enrollment criteria were very similar to those of the NINDS rtPA stroke study. Primary efficacy and points were the number of patients with a decrease of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours and day 30, along with infarct volume at day 30. Secondary end points included mortality and functional recoveries on the Barthel Index and Modified Rankin scale at days 30 and 90. Results - A total of 142 patients were enrolled at 42 sites in North America, including 22 3 hours after onset.

Original languageEnglish (US)
Pages (from-to)811-816
Number of pages6
JournalStroke
Volume31
Issue number4
StatePublished - Apr 2000

Fingerprint

Tissue Plasminogen Activator
Multicenter Studies
Stroke
Placebos
North America
Safety
National Institute of Neurological Disorders and Stroke
Thrombolytic Therapy
National Institutes of Health (U.S.)
Double-Blind Method
Mortality

Keywords

  • Stroke
  • Therapy
  • Thrombolysis
  • Tissue plasminogen activator

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

The rtPA (Alteplase) 0- to 6-hour acute stroke trial, part A (A0276g) : Results of a double-blind, placebo-controlled, multicenter study. / Clark, Wayne; Albers, Gregory W.; Madden, Kenneth P.; Hamilton, Scott.

In: Stroke, Vol. 31, No. 4, 04.2000, p. 811-816.

Research output: Contribution to journalArticle

Clark, Wayne ; Albers, Gregory W. ; Madden, Kenneth P. ; Hamilton, Scott. / The rtPA (Alteplase) 0- to 6-hour acute stroke trial, part A (A0276g) : Results of a double-blind, placebo-controlled, multicenter study. In: Stroke. 2000 ; Vol. 31, No. 4. pp. 811-816.
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