Skip to main content
SpringerLink
Log in

Alteplase Treatment in Acute Stroke: Incorporating Food and Drug Administration Prescribing Information into Existing Acute Stroke Management Guide

  • Cardiovascular Disease and Stroke (S. Prabhakaran, Section Editor)
  • Published:
Current Atherosclerosis Reports Aims and scope Submit manuscript

Abstract

Despite strong evidence that intravenous tissue plasminogen activator (tPA) improves outcomes in acute ischemic stroke patients, its use in clinical practice remains modest. Complex eligibility criteria have been postulated as barriers to greater utilization. Further complicating this has been multiple guidelines and prescribing labels that have been published since first being approved for use in 1996. In this review, several warning and exclusion criteria for tPA in acute ischemic stroke are reviewed with the goal of providing readers a nuanced understanding of historical context and available evidence to make informed decision.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: • Of importance•• Of major importance

  1. Nasr DM, Brinjikji W, Cloft HJ, Rabinstein AA. Utilization of intravenous thrombolysis is increasing in the United States. Int J Stroke. 2013;8:681–8.

    Article  PubMed  Google Scholar 

  2. Jauch EC, Saver JL, Adams Jr HP, Bruno A, Connors JJ, Demaerschalk BM, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:870–947. This is the most current evidence based guidelines governing the assessment and treatment of patients with acute ischemic stroke.

    Article  PubMed  Google Scholar 

  3. Karlinski M, Kobayashi A, Mikulik R, Sanak D, Wahlgren N, Czlonkowska A. Intravenous alteplase in ischemic stroke patients not fully adhering to the current drug license in central and eastern Europe. Int J Stroke. 2012;7:615–22.

    Article  PubMed  Google Scholar 

  4. Karlinski M, Kobayashi A, Litwin T, Sobolewski P, Fryze W, Romanowicz S, et al. Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland. Neurol Neurochir Pol. 2012;46:3–14.

    PubMed  Google Scholar 

  5. Cucchiara BL, Jackson B, Weiner M, Messe SR. Usefulness of checking platelet count before thrombolysis in acute ischemic. Stroke. 2007;38:1639–40.

    Article  PubMed  Google Scholar 

  6. Mazya M, Egido JA, Ford GA, Lees KR, Mikulik R, Toni D, et al. Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe Implementation of Treatments in Stroke (SITS) symptomatic intracerebral hemorrhage risk score. Stroke. 2012;43:1524–31.

    Article  CAS  PubMed  Google Scholar 

  7. Menon BK, Saver JL, Prabhakaran S, Reeves M, Liang L, Olson DM, et al. Risk score for intracranial hemorrhage in patients with acute ischemic stroke treated with intravenous tissue-type plasminogen activator. Stroke. 2012;43:2293–9. This is a very helpful post thrombolysis intracranial hemorrhage risk scoring system.

    Article  CAS  PubMed  Google Scholar 

  8. Wallis WE, Donaldson I, Scott RS, Wilson J. Hypoglycemia masquerading as cerebrovascular disease. Ann Neurol. 1985;18(4):510–2.

    Article  CAS  PubMed  Google Scholar 

  9. Demchuk AM, Tanne D, Hill MD, Kasner SE, Hanson S, Grond M, et al. Predictors of good outcome after intravenous tPA for acute ischemic stroke. Neurology. 2001;57:474–80.

    Article  CAS  PubMed  Google Scholar 

  10. Recombinant tissue plasminogen activator for minor strokes: the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study experience. Ann Emerg Med. 2005;46:243–52.

  11. Hassan AE, Hassanzadeh B, Tohidi V, Kirmani JF. Very mild stroke patients benefit from intravenous tissue plasminogen activator without increase of intracranial hemorrhage. South Med J. 2010;103:398–402.

    Article  PubMed  Google Scholar 

  12. Steffenhagen N, Hill MD, Poppe AY, Buchan AM, Coutts SB. Should you thrombolyse all or any stroke patients with baseline National Institutes of Health stroke scale scores < or =5? Cerebrovasc Dis. 2009;28:201–2.

    Article  PubMed  Google Scholar 

  13. Kohrmann M, Nowe T, Huttner HB, Engelhorn T, Struffert T, Kollmar R, et al. Safety and outcome after thrombolysis in stroke patients with mild symptoms. Cerebrovasc Dis. 2009;27:160–6.

    Article  CAS  PubMed  Google Scholar 

  14. Baumann CR, Baumgartner RW, Gandjour J, von Budingen HC, Siegel AM, Georgiadis D. Good outcomes in ischemic stroke patients treated with intravenous thrombolysis despite regressing neurological symptoms. Stroke. 2006;37:1332–3.

    Article  PubMed  Google Scholar 

  15. Smith EE, Fonarow GC, Reeves MJ, Cox M, Olson DM, Hernandez AF, et al. Outcomes in mild or rapidly improving stroke not treated with intravenous recombinant tissue-type plasminogen activator: findings from Get With The Guidelines-Stroke. Stroke. 2011;42:3110–5.

    Article  CAS  PubMed  Google Scholar 

  16. Barber PA, Zhang J, Demchuk AM, Hill MD, Buchan AM. Why are stroke patients excluded from TPA therapy? An analysis of patient eligibility. Neurology. 2001;56:1015–20.

    Article  CAS  PubMed  Google Scholar 

  17. Balucani C, Levine SR. Mild stroke and rapidly improving symptoms: it’s not always a happy ending. Stroke. 2011;42:3005–7.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Levine SR, Khatri P, Broderick JP, Grotta JC, Kasner SE, Kim D, Meyer BC, Panagos P, Romano J, Scott P. Review, historical context, and clarifications of the NINDS rt-PA stroke trials exclusion criteria: part 1: rapidly improving stroke symptoms. Stroke. 2013.

  19. Patel SC, Levine SR, Tilley BC, et al. Lack of clinical significance of early ischemic changes on computed tomography in acute stroke. JAMA. 2001;286(22):2830–8. doi:10.1001/jama.286.22.2830.

    Article  CAS  PubMed  Google Scholar 

  20. Demchuk AM, Hill MD, Barber PA, Silver B, Patel SC, Levine SR. Importance of early ischemic computed tomography changes using ASPECTS in NINDS rtPA Stroke Study. Stroke. 2005;36:2110–5.

    Article  PubMed  Google Scholar 

  21. Arnold M, Steinlin M, Baumann A, Nedeltchev K, Remonda L, Moser SJ, et al. Thrombolysis in childhood stroke: report of 2 cases and review of the literature. Stroke. 2009;40:801–7.

    Article  CAS  PubMed  Google Scholar 

  22. Amlie-Lefond C, Chan AK, Kirton A, deVeber G, Hovinga CA, Ichord R, et al. Thrombolysis in acute childhood stroke: design and challenges of the thrombolysis in pediatric stroke clinical trial. Neuroepidemiology. 2009;32:279–86.

    Article  PubMed  Google Scholar 

  23. Bhatnagar P, Sinha D, Parker RA, Guyler P, O’Brien A. Intravenous thrombolysis in acute ischaemic stroke: a systematic review and meta-analysis to aid decision making in patients over 80 years of age. J Neurol Neurosurg Psychiatry. 2011;82:712–7.

    Article  PubMed  Google Scholar 

  24. Wardlaw JM, Murray V, Berge E, del Zoppo G, Sandercock P, Lindley RL, et al. Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet. 2012;379:2364–72.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Guillan M, Alonso-Canovas A, Garcia-Caldentey J, Sanchez-Gonzalez V, Hernandez-Medrano I, Defelipe-Mimbrera A, et al. Off-label intravenous thrombolysis in acute stroke. Eur J Neurol. 2012;19:390–4.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Mayo Clinic College of Medicine, Rochester, MN, USA

    Bart M. Demaerschalk

  2. Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ, 85054, USA

    Bart M. Demaerschalk

Authors
  1. Bart M. Demaerschalk
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Bart M. Demaerschalk.

Ethics declarations

Conflict of Interest

Bart M. Demaerschalk declares no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

This article is part of the Topical Collection on Cardiovascular Disease and Stroke

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Demaerschalk, B.M. Alteplase Treatment in Acute Stroke: Incorporating Food and Drug Administration Prescribing Information into Existing Acute Stroke Management Guide. Curr Atheroscler Rep 18, 53 (2016). https://doi.org/10.1007/s11883-016-0602-5

Download citation

  • Published:

  • DOI: https://doi.org/10.1007/s11883-016-0602-5

Keywords

Search

Navigation