Abstract
Background: Despite advances in intravenous thrombolysis and endovascular thrombectomy, numerous acute ischemic stroke survivors continue to experience various disability levels. The nitric oxide (NO) donor, Glyceryl Trinitrate (GTN), has been identified as a potential neuroprotective agent against ischemic damage. This study evaluates the safety and preliminary efficacy of intravenous GTN administration in AIS patients. Methods: We conducted a prospective, double-blind, randomized controlled trial at Beijing Luhe Stroke Center (ChiCTR2100046271). AIS patients within 24 hours of onset were evenly divided into GTN or control groups (n=20 each). The GTN group received intravenous GTN (5 mg in 50 ml saline at a rate of 0.4 mg/h for 12.5 h/day over 2 days), while controls were administered an equivalent volume of 0.9% saline. Both groups followed standard Stroke Guidelines for treatment. Safety measures focused on SBP<110mmHg and headache occurrence. Efficacy was assessed via the 90-day modified rankin scale (mRS) and the national institutes of health stroke scale (NIHSS) scores. Results: Of the 40 AIS patients, baseline characteristics such as age, gender, risk factors, and mRS scores showed no significant difference between the groups. Safety measures of SBP<110mmHg and headache occurrence were also comparable. Overall, 90-day mRS(1 vs 1) and NIHSS (1 vs1 )did not significantly differ between groups. However, the GTN-treated group showed a superior NIHSS recovery (ΔNIHSS 4.5 Vs 3, p=0.028), indicating that GTN can well-allow patients to recover within the same time frame. Subgroup analyses revealed a noteworthy benefit of GTN in the 90-day NIHSS score for non-thrombolysis patients (1 vs 2, p=0.016). Moreover, GTN benefited mild stroke patients (NIHSS score <6) at 90 days (p=0.025). Conclusion: The RIGID study confirms the safety of intravenous GTN for AIS patients. Notably, while overall 90-day mRS and NIHSS scores between the GTN and control groups did not significantly vary, the GTN group displayed a pronounced improvement in NIHSS recovery. Additionally, GTN demonstrated particular efficacy for non-thrombolysis patients and those with mild stroke symptoms, suggesting its potential as a tailored intervention in specific AIS subgroups.
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