Ischemic stroke: new agent offers benefit after thrombolytic window closes

  • Ni J & al.
  • BMC Neurol
  • 14 Jul 2020

  • curated by Susan London
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

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.