Efficacy and Safety of Tirofiban in Clinical Patients With Acute Ischemic Stroke

Bin Han; Teng Ma; Zhendong Liu; Yiqun Wu; Weiwei Tan; Shaoyang Sun; Xuemei Li; Changyan Shao; Duyong Tang; Jinping Sun

doi:10.3389/fneur.2021.785836

Efficacy and Safety of Tirofiban in Clinical Patients With Acute Ischemic Stroke

Front Neurol. 2022 Feb 8:12:785836. doi: 10.3389/fneur.2021.785836. eCollection 2021.

Authors

Bin Han¹, Teng Ma², Zhendong Liu³, Yiqun Wu⁴, Weiwei Tan⁵, Shaoyang Sun¹, Xuemei Li⁶, Changyan Shao⁷, Duyong Tang⁸, Jinping Sun^{1

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Affiliations

¹ Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, China.
² Department of Neurology, Qingdao Hospital of Traditional Chinese Medicine (Qingdao Hiser Hospital), Qingdao, China.
³ Department of Neurology, Laixi People's Hospital, Laixi, China.
⁴ Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, China.
⁵ Department of Neurology, Pingdu People's Hospital, Pingdu, China.
⁶ Department of Neurology, Qingdao West Coast New Area Central Hospital, Qingdao, China.
⁷ Department of Pharmacology, Feixian People's Hospital, Linyi, China.
⁸ Department of Neurology, Pingdu Third People's Hospital, Pingdu, China.
⁹ Department of Emergency Internal Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.
¹⁰ National Engineering and Technology Research Center of Chirality Pharmaceutical, Linyi, China.

Abstract

Background: Intravenous thrombolysis and endovascular thrombectomy have been approved for acute ischemic stroke (AIS). However, only a minority of patients received these treatments in China. We aimed to evaluate the efficacy and safety of tirofiban in patients with AIS who were not undergoing early recanalization treatments.

Methods: Patients with mild-to-moderate stroke [National Institutes of Health Stroke Scale (NIHSS) score, 4-15] were enrolled in this study. Patients due to cardiogenic embolism were excluded. Eligible patients within 12 h from symptom onset were randomly assigned (1:1) to receive tirofiban (a loading dose of 0.4 μg/kg/min over 30 min and a maintenance dose of 0.1 μg/kg/min up to 48 h) followed by regular treatment or to receive regular treatment (aspirin at a dose of 100 mg per day for 90 days) (control). The primary outcome was the proportion of favorable functional outcomes at 90 days [defined as the modified Rankin Scale (mRS) score of 0-2]. The secondary outcomes included a shift in the distribution of the mRS scores at 90 days and the NIHSS score at 24 h and 7 days. The primary safety outcome was symptomatic intracranial hemorrhage (sICH) within 7 days after tirofiban treatment.

Results: A total of 380 eligible patients were randomly assigned to the tirofiban group (n = 190) or the control group (n = 190). The proportion of favorable functional outcomes was higher in the tirofiban group (79.1%) than that in the control group (67.8%) at 90 days [odds ratio (OR), 1.80; 95% CI, 1.12-2.90; p = 0.0155]. An improvement was also observed in the overall distribution of the 90-day mRS scores (adjusted common OR, 2.31; 95% CI, 1.58-3.39; p < 0.0001). Additionally, the median NIHSS score was lower in the tirofiban group than in the control group at 7 days (3 vs. 5, p < 0.0001). Next, we observed that the occurrence of sICH did not differ between the two groups.

Conclusion: Our trial supports that tirofiban was safe and effective and might be a remedial treatment for patients with AIS who did not receive recanalization treatments.

Clinical trial registration: http://www.chictr.org.cn/, identifier: ChiCTR2000031297.

Keywords: acute ischemic stroke (AIS); clinical trial; efficacy and safety assessment; modified Rankin Scale (mRS) functional outcome; tirofiban.