Gavestinel does not improve outcome after acute intracerebral hemorrhage: an analysis from the GAIN International and GAIN Americas studies.

Abstract

BACKGROUND AND PURPOSE:

Glycine Antagonist in Neuroprotection (GAIN) International and GAIN Americas trials were prospectively designed, randomized, placebo-controlled trials of gavestinel, a glycine-site antagonist and putative neuroprotectant drug administered within 6 hours of suspected ischemic or hemorrhagic stroke. Both trials reported that gavestinel was ineffective in ischemic stroke. This analysis reports the results in those with primary intracerebral hemorrhage.

METHODS:

The primary hypothesis was that gavestinel treatment did not alter outcome, measured at 3 months by the Barthel Index (BI), from acute intracerebral hemorrhage, based on pooled results from both trials. The BI scores were divided into 3 groups: 95 to 100 (independent), 60 to 90 (assisted independence), and 0 to 55 (dependent) or dead.

RESULTS:

In total, 3450 patients were randomized in GAIN International (N=1804) and GAIN Americas (N=1646). Of these, 571 were ultimately identified to have spontaneous intracerebral hematoma on baseline head computerized tomography scan. The difference in distribution of trichotomized BI scores at 3 months between gavestinel and placebo was not statistically significant (P=0.09). Serious adverse events were reported at similar rates in the 2 treatment groups.

CONCLUSIONS:

These observations from the combined GAIN International and GAIN Americas trials suggest that gavestinel is not of substantial benefit or harm to patients with primary intracerebral hemorrhage. These findings are similar to results previously reported in patients with ischemic stroke.

• Authors: E Clarke Haley Jr, John L P Thompson, Bruce Levin, Stephen Davis, Kennedy R Lees, John G Pittman, Janet T DeRosa, Paul Ordronneau, Devin L Brown, Ralph L Sacco, GAIN Americas and GAIN International Investigators
• Journal: Stroke (Stroke) Vol. 36 Issue 5 Pg. 1006-10 (May 2005) ISSN: 1524-4628 [Electronic] United States
• PMID: 15831831 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 3-(2-((phenylamino)carbonyl)ethenyl)-4,6-dichloroindole-2-carboxylic acid
• Glycine Agents
• Indoles

Topics

• Acute Disease
• Aged
• Cerebral Hemorrhage (diagnosis, drug therapy, mortality)
• Female
• Glycine Agents (adverse effects, therapeutic use)
• Humans
• Indoles (adverse effects, therapeutic use)
• Male
• Stroke (drug therapy)
• Treatment Failure
• United States