Statistical analysis for efficacy of tirofiban combined with ozagrel in the treatment of progressive cerebral infarction patients out of thrombolytic therapy time window

Abstract

OBJECTIVES: To investigate the safety and efficacy of combined tirofiban-ozagrel therapy for treating progressive stroke patients out of thrombolytic therapy time window.

METHODS: This prospective, double-blind, randomized controlled study included 337 patients who had experienced an acute ischemic stroke between November 2017 and December 2018. All patients were randomized into three groups: 1) the tirofiban/ozagrel group (n=113), 2) the tirofiban group (n=110), and 3) the ozagrel group (n=114). The platelet aggregation (PAG), thrombin time (TT), prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen (FIB) levels in the patients from these groups were evaluated before starting treatment and then, at 24h, 7 days, and 14 days after treatment. The National Institutes of Health Stroke Scale (NIHSS) scores were evaluated before treatment and then, 24h, 1 week, 2 weeks, and 4 weeks after treatment. The Barthel Index (BI) score was used to measure safety, and the modified Rankin scale (mRS) was used to evaluate disability following 3 months of treatment. The risk factors affecting clinical outcomes were analyzed using logistic multivariate regression.

RESULTS: The mean NIHSS score for all the patients was 13.17±3.13 before treatment, and no significant difference between the basic clinical parameters of the three patient groups was found. Following treatment, both PAG and FIB were significantly reduced compared with the baseline (p<0.05). The levels of PAG and FIB in the tirofiban/ozagrel group were significantly lower than those in the tirofiban and ozagrel groups at 24h and 7 days after treatment (p<0.05). The NIHSS score decreased significantly in all treatment groups (p<0.05). The tirofiban/ozagrel NIHSS scores were significantly lower than that of the tirofiban and ozagrel groups at 24h, 1 week, and 2 weeks post initiation (p<0.05 for all). There were no significant differences in the BI and mRS scores or the intracranial hemorrhage rates; further, age, sex, Trial of ORG 10172 in acute stroke treatment (TOAST) type, baseline NIHSS and 24-h NIHSS scores, baseline thrombus-related factors, and treatment methods were shown to not be independent risk factors for clinical outcomes.

CONCLUSION: The combination of tirofiban and ozagrel, as well as monotherapy with either tirofiban or ozagrel, transiently improves the neural function of patients and reduces platelet aggregation and fibrinogen formation in the first 4 weeks following a stroke event; additionally, none of these treatments increased the risk for hemorrhage in these progressive stroke patients over a 3-month period.