- 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.
- 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).
- 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).
- 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.
- Unclear generalizability.
- Relatively short follow-up.