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Aptiganel hydrochloride in acute ischemic stroke: a randomized controlled trial
G W Albers1, L B Goldstein, D Hall
1Stanford Stroke Center, 701 Welch Rd, Bldg B, Suite 325, Palo Alto, CA 94304, USA.
JAMA
|December 26, 2001
Summary
Aptiganel did not improve outcomes for acute ischemic stroke patients and may be harmful. Further research into glutamate blockade in stroke is warranted, considering potential detrimental effects.
Area of Science:
- Neuroscience
- Clinical Trials
- Pharmacology
Background:
- Tissue plasminogen activator is the primary treatment for acute ischemic stroke but has limitations.
- Aptiganel hydrochloride is a novel N-methyl-D-aspartate receptor antagonist investigated for neuroprotection.
Purpose of the Study:
- To evaluate the efficacy of aptiganel in improving clinical outcomes for acute ischemic stroke patients.
Main Methods:
- A nested phase 2/3 randomized controlled trial involved 628 patients across 156 centers.
- Patients received high-dose aptiganel, low-dose aptiganel, or placebo within 6 hours of stroke onset.
- The primary endpoint was the Modified Rankin Scale score at 90 days; secondary endpoints included mortality and NIH Stroke Scale changes.
Main Results:
- The trial was halted due to lack of efficacy and potential mortality imbalance.
- No significant improvement in Modified Rankin Scale scores was observed for either aptiganel dose compared to placebo.
- Higher mortality rates were noted in the high-dose aptiganel group (26.3%) versus placebo (19.2%).
Conclusions:
- Aptiganel demonstrated no efficacy in treating acute ischemic stroke at the tested doses and may be harmful.
- The results suggest potential detrimental effects of glutamate blockade with aptiganel in undifferentiated stroke populations.
