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Cited by 154Acute Ischemic Stroke ManagementNeurological Disorders and TreatmentsStroke Rehabilitation and Recovery

Treatment of Acute Ischemic Stroke With Piracetam

De Deyn, Peter Paul, De Reuck, Jacques, Deberdt, Walter, Vlietinck, Robert, Orgogozo, Jean-Marc·1997·Stroke
DOI 10.1161/01.str.28.12.2347
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Abstract

Background and Purpose Piracetam, a nootropic agent with neuroprotective properties, has been reported in pilot studies to increase compromised regional cerebral blood flow in patients with acute stroke and, given soon after onset, to improve clinical outcome. We performed a multicenter, randomized, double-blind trial to test whether piracetam conferred benefit when given within 12 hours of the onset of acute ischemic stroke to a large group of patients. Methods Patients received placebo or 12 g piracetam as an initial intravenous bolus, 12 g daily for 4 weeks and 4.8 g daily for 8 weeks. The primary end point was neurologic outcome after 4 weeks as assessed by the Orgogozo scale. Functional status at 12 weeks as measured by the Barthel Index was the major secondary outcome. CT scan was performed within 24 hours of the onset of stroke but not necessarily before treatment. Analyses based on the intention to treat were performed in all randomized patients (n=927) and in an “early treatment” population specified in the protocol as treatment within 6 hours of the onset of stroke but subsequently redefined as less than 7 hours after onset (n=452). Results In the total population, outcome was similar with both treatments (the mean Orgogozo scale after 4 weeks: piracetam 57.7, placebo 57.6; the mean Barthel Index after 12 weeks: piracetam 55.8, placebo 53.1). Mortality at 12 weeks was 23.9% (111/464) in the piracetam group and 19.2% (89/463) in the placebo group (relative risk 1.24, 95% confidence interval, 0.97 to 1.59; P =.15). Deaths were fewer in the piracetam group in those patients in the intention-to-treat population admitted with primary hemorrhagic stroke. Post hoc analyses in the early treatment subgroup showed differences favoring piracetam relative to placebo in mean Orgogozo scale scores after 4 weeks (piracetam 60.4, placebo 54.9; P =.07) and Barthel Index scores at 12 weeks (piracetam 58.6, placebo 49.4; P =.02). Additional analyses within this subgroup, confined to 360 patients with moderate and severe stroke (initial Orgogozo scale score <55), showed significant improvement on piracetam in both outcomes ( P <.02). Conclusions Piracetam did not influence outcome when given within 12 hours of the onset of acute ischemic stroke. Post hoc analyses suggest that piracetam may confer benefit when given within 7 hours of onset, particularly in patients with stroke of moderate and severe degree. A randomized, placebo-controlled, multicenter study, the Piracetam Acute Stroke Study II (PASS II) will soon begin.

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Crossref · 10.1161/01.str.28.12.2347

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  • In the PASS trial of piracetam, the trend to an increase in death was related to an imbalance in severity at baseline.

    “An example is the trend to an increase in death in the Postural Assessment Scale for Stroke Patients (PASS) trial of piracetam, which was related to an imbalance in severity at baseline.”

    From Statistical Analysis of the Primary Outcome in Acute Stroke Trials (2012) · cites this paper as [43]

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Authors
De Deyn, P. P., De Reuck, J., Deberdt, W., Vlietinck, R., & Orgogozo, J.-M.
Affiliations
  • From the Department of Neurology, Middelheim Hospital and University of Antwerp, Belgium (P.P.D.D.), Department of Neurology, University Hospital, Ghent, Belgium (J.D.R.), Department of Clinical Research and Development, UCB Pharma, Braine-l’Alleud, Belgium (W.D.), Department of Genetic Epidemiology, University of Louvain, Belgium (R.V.), and Department of Neurology, Pellegrin Hospital, University of Bordeaux II, Bordeaux, France (J-M.O.).
  • University of Antwerp (BE)
ORCID
Vlietinck, Robert
Venue
Stroke
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
1997-12
Volume
28
Issue
12
Pages
2347-2352
ISSN
  • 0039-2499 (ISSN-L)
  • 1524-4628
DOI
10.1161/01.str.28.12.2347
OpenAlex
W2121347730
Cited by
154
References
26
Citations by year
2025: 1 · 2023: 3 · 2022: 2 · 2021: 3 · 2020: 2 · 2019: 3 · 2018: 1 · 2017: 7 · 2016: 1 · 2015: 3 · 2014: 7 · 2013: 1 · 2012: 4
FWCI
13.74
Type
journal article
Language
en
Open access
closed
Locations
  • Stroke (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
  • Life Sciences › Neuroscience › Neurology › Neurological Disorders and Treatments
  • Health Sciences › Medicine › Rehabilitation › Stroke Rehabilitation and Recovery
Keywords
piracetam, acute ischemic stroke, nootropic drugs, neuroprotection, early treatment, functional outcome, mortality, hemorrhagic stroke, regional cerebral blood flow, Barthel Index, stroke rehabilitation, intention-to-treat analysis, secondary stroke prevention
MeSH terms
Acute Disease, Aged, Aged, 80 and over, Brain Ischemia, Cerebrovascular Disorders, Double-Blind Method, Female, Humans, Male, Middle Aged, Piracetam, Survival Analysis, Treatment Outcome, Neuroprotective Agents, Nootropic Agents

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