Clopidogrel Of Load Dosage To Treat Acute Cerebral Infarction/TIA

Objective: To design a multicenters, prospective, randomized, controled clinical trial for preliminary efficacy and safety evaluation of loading dosage of Clopidogrel in the treatment of acute cerebral infarction /TIA; To evaluate and improve the trial design through a pilot study for the basis setup of further double blind trial.Methods: According to the methods of clinical trials, and referring to the published prospective clinical trials' design for acute cerebral infarction, a prospective randomized, controlled trial was designed. Main inclusion criteria: acute cerebral infarction or TIA within 48h. The included patients were randomized divided into load dosage group and non-load dosage group. Main outcomes: progressive or recurrence rate within 7 days; efficacy rate at 28 days; death and dependency rate and good outcome rate at 28 days, 90 days, respectively; and safety. According to the design, 4 medical centers were chosen as the candidates to attend the pilot study.Result:1) The preliminary trial design and the performance protocol were completed. From July, 2005 to March, 2006, 71 patients with completed follow-up from 3 medical centers have been enrolled in this pilot study, while another center exited this study because of failing to treat patients according to the trial design. During the processes of the pilot study, the trial design was proved to be feasible. Certain details, however, have to be modified, especially the study quality controlling as well as the monitoring of safety has to be further strengthened.2) Results of preliminary pilot study: data from 71 patients were analyzed. The preliminary results showed that the relative risk reduction (RRR) in load dosage of Clopidogrel was 55.8% (95% CI: -14.2～82.9%) with non-statistic difference (P=0.077) as compared with non-load dosage group. The RRR of death or dependence rate at 28 days and 90 days in load dosage group was 16.7% (95%CI, -54.1～54.9%, P = 0.560), 35.2% (95% CI: -39.2～69.8%, P=0.259), respectively. The efficacy rate at 28 days in load dosage group was 52.8%, in non-load dosage group 37.14%, with no significant difference (P=0.186). The load dosage group showed a better tendency of good outcome rate than non-load dosage group at 28 days, 90 days, respectively, without statistic difference. No safety difference between both groups was found (P>0.05).