Ischemic stroke: new agent offers benefit after thrombolytic window closes

  • Ni J & al.
  • BMC Neurol
  • 14/07/2020

  • Susan London
  • Clinical Essentials
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Takeaway

  • Cinepazide (a calcium channel blocker and adenosine potentiator) improved functional outcomes in patients with acute ischemic stroke having delayed presentation and not receiving thrombolytic therapy.

Why this matters

  • Thrombolytic therapy must be given within roughly 4.5 hours and is contraindicated in some patients.

Key results

  • At 90 days, the cinepazide group vs the placebo group had a higher rate of:
    • Modified Rankin scale score ≤2 (60.9% vs 50.1%; P<.001>
    • Barthel Index ≥95 (53.4% vs 46.7%; P=.0230).
  • Death rate: 1.5% with cinepazide vs 2.0% with placebo.
  • Groups similar on:
    • Adverse events overall (82.0% vs 84.1%; P=.30).
    • Serious adverse events (9.6% vs 11.4%; P=.30).
    • Leading adverse event of constipation (26.0% vs 26.5%; P=.82).
  • Cinepazide group had lower rate of hypokalemia (6.1% vs 10.5%; P<.001>

Study design

  • Chinese multicenter phase 4 (postmarketing) randomized controlled trial among 937 patients with first acute ischemic stroke, anterior circulation:
    • Onset a mean (standard deviation) of 30.9 (11.4) hours earlier.
    • NIH Stroke Scale score of 7-25.
  • Randomization: intravenous infusion of 320 mg cinepazide maleate vs placebo once daily for 14 days, double-blind.
  • All patients received intravenous citicoline sodium, medical therapy.
  • Main outcome: modified Rankin scale score ≤2 on day 90.
  • Funding: Peking Sihuan Pharmaceutical Company.

Limitations

  • Unclear generalizability.
  • Relatively short follow-up.