Dengzhanxixin injection for acute ischemic stroke after reperfusion therapy: A double-blind, placebo-controlled,...

Revascularization for acute ischemic stroke (AIS) can salvage at-risk brain tissue, but reperfusion injury may reduce their benefits. This study aims to evaluate the efficacy and safety of Dengzhanxixin (DZXX) injection in AIS patients receiving reperfusion therapy.

The DAISY (Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion TherapY) is a multicenter, randomized, double-blind, placebo-controlled, dose-exploration clinical trial. AIS patients who received reperfusion therapy were randomly assigned in a 1:1:1 ratio: high-dose (80 mg per day) DZXX injection, low-dose (40 mg per day) DZXX injection, and placebo, for 10-14 consecutive days. The primary efficacy outcome was the proportion of participants with modified Rankin Scale (mRS) score (0-1) at 90 days. The safety outcome was any adverse event within 90 days after treatment.

Between September 2022 and August 2023, a total of 246 patients from 17 centers were enrolled, with 78 assigned to high-dose group, 89 to low-dose group, and 79 to placebo group. At 90-days, the proportion of participants with a mRS score of 0 or 1 was 78.21 % in high-dose, 77.53 % in low-dose, and 65.82 % in placebo (high-dose vs. placebo, OR, 1.85, 95 % CI, 0.91-3.77, P = 0.11; low-dose vs. placebo, OR, 1.75; 95 % CI, 0.88-3.48, P = 0.09). No significant differences observed in adverse events among three groups (P = 0.154).

DZXX injection demonstrated a trend toward improved functional outcomes at 90-days, but the differences were not statistically significant. It would be safe for patients with AIS undergoing reperfusion therapy without increasing the risk of bleeding.