[1]Department of Neurology and Stroke Center, First Affiliated Hospital of Jinan University, Guangzhou, China.
Background: To evaluate the efficacy and safety of clopi-dogrel with loading dose in treating acute non-cardiogenic ischemic stroke. Methods: CLASS-China was a prospectively, randomized, double-blinded, placebo-controlled trial in mainland China. Patients with partial anterior circulation cerebral infarction due to acute non-cardiogenic ischemic stroke had been enrolled. The onset time must within 48 hours, and the patients with thrombolysis were excluded. Patients were divided into loading dose group and routine dose group. The primary outcome was the incidence of recurrence of stroke or stroke in progression (SIP) with 7 days. Life- threatening bleeding was defined as the primary safety outcome. An intension-to treat analysis was used for the statistic analysis. Results: From Feb. 28, 2008 to Mar. 2010, 16 centers and 303 patients were recruited into this study. The demo-graphic characteristics and baseline data showed no significant differences between the two groups. The total primary outcome was 15.5%, and there was no difference between the two groups (loading dosage group 16.1% (24/ 149) and control group 14.9% (22/148), respectively, P = 0.782). The non-dependence rate in loading dose group (80.4%) was slightly higher than that in controlled group (76.6%). Fatal bleeding was found in 2 cases (1.3%) in loading dose group and 4 cases (2.7%) in control group. There was no significant difference in adverse events or severe adverse events in both groups. Conclusions: This trial failed to show benefit of loading dose over standard dose of clopidogrel in patients with acute non-cardiogenic ischemic stroke. Further study about the use of clopidogrel in acute ischemic stroke patients is needed.
(8.0+极速模式)