RODIN
Trial question
What is the role of nelonemdaz in patients with AIS after mechanical reperfusion?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 457
457 patients (203 female, 254 male).
Inclusion criteria: patients with AIS who have undergone endovascular thrombectomy within 12 hours after stroke onset.
Key exclusion criteria: contraindication to contrast media for brain imaging; RRT at screening; diagnosis of cancer or receipt of cancer therapy in the past 6 months; liver cirrhosis; pregnancy or lactation.
Interventions
N=232 nelonemdaz (first intravenous infusion of 750 mg followed by 500 mg BID for 5 days).
N=225 placebo (matching saline infusions BID for 5 days).
Primary outcome
Median modified Rankin Scale score at 12 weeks
2 points
2 points
2.0 points
1.5 points
1.0 points
0.5 points
0.0 points
Nelonemdaz
Placebo
No significant
difference ↔
No significant difference in median mRS score at 12 weeks (2 points vs. 2 points; OR 0.95, 95% CI 0.69 to 1.31).
Secondary outcomes
No significant difference in mRS score of 0-2 at 12 weeks (52.6% vs. 53.8%; OR 0.98, 95% CI 0.82 to 1.16).
No significant difference in NIHSS 0-4 scores at 12 weeks (64.8% vs. 62.4%; OR 1.04, 95% CI 0.89 to 1.21).
No significant difference in symptomatic ICH within 24 hours of the last dose of treatment onset (2.7% vs. 0.9%; HR 2.91, 95% CI 0.59 to 14.25).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with AIS who have undergone endovascular thrombectomy within 12 hours after stroke onset, nelonemdaz was not superior to placebo with respect to median mRS score at 12 weeks.
Reference
Jin Soo Lee, Hyun Goo Kang, Seong Hwan Ahn et al. Nelonemdaz and Patients With Acute Ischemic Stroke and Mechanical Reperfusion: The RODIN Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456535.
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