Browsing by Author "Bousser, M.G."

Now showing 1 - 3 of 3

Baseline characteristics and treatment response of patients from the Philippines in the CHIMES study
(Wiley-Blackwell, 2014) Navarro, J.C.; Gan, H.H.; Lao, A.Y.; Baroque, A.C.; Hiyadan, J.H.; Chua, C.L.; San Jose, M.C.; Advincula, J.M.; Lee, C.F.; Bousser, M.G.; Chen, C.L.; CHIMES Study Investigators (38); de Silva, H.A. CHIMES Study Investigator; Ranawaka, U. CHIMES Study Investigator; Wijekoon, N. CHIMES Study Investigator
BACKGROUND: The CHIMES Study compared MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 72 h. Sites from the Philippines randomized 504 of 1099 (46%) patients in the study. We aimed to define the patient characteristics and treatment responses in this subgroup to better plan future trials. METHODS: The CHIMES dataset was used to compare the baseline characteristics, time from stroke onset to study treatment initiation, and treatment responses to MLC601 between patients recruited from Philippines and the rest of the cohort. Treatment effect was analyzed using end-points at month 3 as described in the primary publication, that is, modified Rankin Score, National Institutes of Health Stroke Scale, and Barthel Index. RESULTS: The Philippine cohort was younger, had more women, worse baseline National Institutes of Health Stroke Scale, and longer time delay from stroke onset to study treatment compared with the rest of the cohort. Age (P = 0•003), baseline National Institutes of Health Stroke Scale (P < 0•001), and stroke onset to study treatment initiation (P = 0•016) were predictors of modified Rankin Score at three-months. Primary analysis of modified Rankin Score shift was in favor of MLC601 (adjusted odds ratio 1•41, 95% confidence interval 1•01–1•96). Secondary analyses were likewise in favor of MLC601 for modified Rankin Score dichotomy 0–1, improvement in National Institutes of Health Stroke Scale (total and motor scores), and Barthel Index. CONCLUSIONS: The treatment effects in the Philippine cohort were in favor of MLC601. This may be due to inclusion of more patients with predictors of poorer outcome.
Chinese medicine neuroaid efficacy on stroke recovery: a double-blind, placebo-controlled, randomized study
(Lippincott Williams and Wilkins, 2013) Chen, C.L.; Young, S.H.; Gan, H.H.; Singh, R.; Lao, A.Y.; Baroque, A.C.; Chang, H.M.; Hiyadan, J.H.; Chua, C.L.; Advincula, J.M.; Muengtaweepongsa, S.; Chan, B.P.; de Silva, H.A.; Towanabut, S.; Suwanwela, N.C.; Poungvarin, N.; Chankrachang, S.; Wong, K.S.; Eow, G.B.; Navarro, J.C.; Venketasubramanian, N.; Lee, C.F.; Bousser, M.G.; CHIMES Study Investigators
BACKGROUND AND PURPOSE: Previous clinical studies suggested benefit for post stroke recovery when MLC601 was administered between 2 weeks and 6 months of stroke onset. The Chinese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study tested the hypothesis that MLC601 is superior to placebo in acute, moderately severe ischemic stroke within a 72-hour time window. METHODS: This multicenter, double-blind, placebo-controlled trial randomized 1100 patients with a National Institutes of Health Stroke Scale score 6 to 14, within 72 hours of onset, to trial medications for 3 months. The primary outcome was a shift in the modified Rankin Scale. Secondary outcomes were modified Rankin Scale dichotomy, National Institutes of Health Stroke Scale improvement, difference in National Institutes of Health Stroke Scale total and motor scores, Barthel index, and mini-mental state examination. Planned subgroup analyses were performed according to age, sex, time to first dose, baseline National Institutes of Health Stroke Scale, presence of cortical signs, and antiplatelet use. RESULTS: The modified Rankin Scale shift analysis-adjusted odds ratio was 1.09 (95% confidence interval, 0.86-1.32). Statistical difference was not detected between the treatment groups for any of the secondary outcomes. Subgroup analyses showed no statistical heterogeneity for the primary outcome; however, a trend toward benefit in the subgroup receiving treatment beyond 48 hours from stroke onset was noted. Serious and nonserious adverse events rates were similar between the 2 groups.CONCLUSIONS:MLC601 is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity. Longer treatment duration and follow-up of participants with treatment initiated after 48 hours may be considered in future studies. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00554723.
Effects of MLC601 on early vascular events in patients after stroke: the CHIMES study
(Lippincott Williams and Wilkins, 2013) Chen, C.L.; Venketasubramanian, N.; Lee, C.F.; Wong, K.S.; Bousser, M.G.; CHIMES Study Investigators; de Silva, A. with 38 CHIMES Study Investigators
BACKGROUND AND PURPOSE: Early vascular events are an important cause of morbidity and mortality in the first 3 months after a stroke. We aimed to investigate the effects of MLC601 on the occurrence of early vascular events within 3 months of stroke onset. METHODS: Post hoc analysis was performed on data from subjects included in the CHInese Medicine Neuroaid Efficacy on Stroke recovery(CHIMES) study, a randomized, placebo-controlled, double-blinded trial that compared MLC601 with placebo in 1099 subjects with ischemic stroke of intermediate severity in the preceding 72 hours. Early vascular events were defined as a composite of recurrent stroke, acute coronary syndrome, and vascular death occurring within 3 months of stroke onset. RESULTS: The frequency of early vascular events during the 3-month follow-up was significantly less in the MLC601 group than in the placebo group (16 [2.9%] versus 31 events [5.6%]; risk difference=-2.7%; 95% confidence interval, -5.1% to -0.4%; P=0.025) without an increase in nonvascular deaths. Kaplan-Meier survival analysis showed a difference in the risk of vascular outcomes between the 2 groups as early as the first month after stroke (Log-rank P=0.024; hazard ratio, 0.51; 95% confidence interval, 0.28-0.93). CONCLUSIONS: Treatment with MLC601 was associated with reduced early vascular events among subjects in the CHIMES study. The mechanisms for this effect require further study. CLINICAL TRIAL REGISTRATION URL://www.clinicaltrials.gov. Unique identifier: NCT00554723.