SAINT II
Stroke - Acute Ischemic - NXY-059 (Cerovive) Treatment
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Status:
Completed. Trial concluded with 3306 patients recruited and results published August 2007.
Purpose:
To assess the efficacy and safety of intravenous NXY-059 in acute ischemic stroke within six hours of symptom onset.
Interventions:
NXY-059
Antioxidant; nitrone spin-trap agent.
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Location(s):
Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America.
Year Started:
2005
Year Finished:
2006
Design:
Multi-national, multicenter, randomized, double-blind, placebo controled, safety and efficacy study.
Inclusion Criteria
Patients are eligible for inclusion following clinical diagnosis of ischemic stroke with limb weakness and a National Institutes of Health Stroke Scale (NIHSS) score of ≥6.
Exclusion Criteria
Patients with a severe illness with life expectancy less than 6 months, known severe kidney disorder, current known alcohol or illicit drug abuse or dependence, treatment with acetazolamide and methotrexate is not permitted during the infusion, participat
Patient Involvement:
Patients will be randomized to either the placebo control group or the treatment group to receive a one hour loading dose of NXY-059 followed by 71 hours of hourly infusion to obtain a target unbound plasma concentration of 260 μmol/L.
Primary Outcome:
Overall recovery and recovery of motor function after ischemic stroke as measured by the modified Rankin Scale at 90 days.
Secondary Outcome:
The NIHSS and other efficacy outcomes, including the Barthel Index, will be considered formally significant only if analyses higher in the hierarchy of statistical testing reach significance.
Results:
The efficacy analysis was based on 3195 patients. Prognostic factors were well balanced between the treatment groups. Mortality was equal in the two groups, and adverse-event rates were similar. The distribution of scores on the modified Rankin scale did not differ between the group treated with NXY-059 (1588 patients) and the placebo group (1607 patients; P=0.33 by the Cochran-Mantel-Haenszel test; odds ratio for limiting disability, 0.94; 95% confidence interval [CI], 0.83 to 1.06). Analysis of categorized scores on the modified Rankin scale confirmed the lack of benefit: the odds ratio for trichotomization into modified Rankin scale scores of 0 to 1 versus 2 to 3 versus 4 to 6 was 0.92 (95% CI, 0.80 to 1.06). There was no evidence of efficacy for any of the secondary end points. Among patients treated with alteplase, there was no difference between the NXY-059 group and the placebo group in the frequency of symptomatic or asymptomatic hemorrhage. In conclusion, NXY-059 is ineffective for the treatment of acute ischemic stroke within 6 hours after the onset of symptoms.
Source of Information:
AstraZeneca press release.
ClinicalTrials.
Presented at the 2006 International Stroke Conference [February 2006].
Press release [August 2007].
N Engl J Med. 2007 Aug 9;357(6):562-71.
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Web Links and Publications:
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This information last updated on: 7/21/2009
Reviewed on: 05/19/2009.
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