Dengzhanxixin injection for acute ischemic stroke after reperfusion therapy: A double-blind, placebo-controlled, multi-center clinical trial.
Dengzhanxixin injection showed a non-significant trend towards improved outcomes in stroke patients post-reperfusion, with no increase in adverse events.
Where it sits
this study against the rest of the cjc-1295 corpusSummary and findings
This study evaluated the efficacy and safety of Dengzhanxixin (DZXX) injection in acute ischemic stroke patients receiving reperfusion therapy. Patients were randomized to receive high-dose, low-dose, or placebo for 10-14 days. At 90 days, no statistically significant improvement in modified Rankin Scale scores was observed.
Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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 <i>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).</i><h4>Conclusion</h4>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.
Background
Acute ischemic stroke (AIS) treatment aims to restore blood flow to salvageable brain tissue, but reperfusion can lead to injury that diminishes therapeutic benefits. This study investigates whether Dengzhanxixin (DZXX) injection can improve outcomes in AIS patients after reperfusion therapy. Previous research has not conclusively established the efficacy of DZXX in this context, making this study relevant for potential therapeutic advancements.
Methods
The study was a multicenter, randomized, double-blind, placebo-controlled trial involving 246 AIS patients who received reperfusion therapy. Participants were randomized into three groups: high-dose DZXX (80 mg/day), low-dose DZXX (40 mg/day), and placebo. Treatment lasted 10-14 days. The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days. Safety was assessed by monitoring adverse events within 90 days post-treatment.
Results
At 90 days, 78.21% of patients in the high-dose group and 77.53% in the low-dose group achieved an mRS score of 0 or 1, compared to 65.82% in the placebo group. The odds ratio for high-dose versus placebo was 1.85 (95% CI, 0.91-3.77, P=0.11), and for low-dose versus placebo was 1.75 (95% CI, 0.88-3.48, P=0.09). No significant differences were observed in adverse events across the groups (P=0.154).
Interpretation
The study found a trend towards better functional outcomes with DZXX treatment, but the differences were not statistically significant, suggesting limited clinical impact. The lack of statistical significance may be due to insufficient sample size or variability in patient response. These findings align with previous studies that show potential but inconclusive benefits of DZXX. Further research with larger sample sizes is needed to confirm these results.
Key findings
- 78.21% with mRS 0-1 at 90 days in high-dose group
- 77.53% with mRS 0-1 at 90 days in low-dose group
- 65.82% with mRS 0-1 at 90 days in placebo group
- OR for high-dose vs placebo: 1.85, 95% CI 0.91-3.77, P=0.11
- No significant difference in adverse events, P=0.154
Limitations
- No statistical significance in primary outcome
- Sample size may be insufficient
- Short follow-up duration of 90 days
- Potential variability in patient response