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

Other earlier research your doctor and hospital should consider. 

Safety of Tirofiban in acute Ischemic Stroke: the SaTIS trial

Safety and preliminary efficacy of early tirofiban treatment after alteplase in acute ischemic stroke patients

Tirofiban for acute ischemic stroke: systematic review and meta-analysis

Endovascular stroke therapy: tirofiban is associated with risk of fatal intracerebral hemorrhage and poor outcome

The latest here:

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

Bin Han^1†, Teng Ma^2†, Zhendong Liu³, Yiqun Wu⁴, Weiwei Tan⁵, Shaoyang Sun¹, Xuemei Li⁶, Changyan Shao⁷, Duyong Tang⁸ and Jinping Sun^1,9,10*

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

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.

Introduction

Acute ischemic stroke (AIS) is commonly characterized by high disability and mortality rates, and it has become the leading cause of death in China (1). For AIS treatment, extraordinary progresses including intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) and endovascular thrombectomy (EVT) have been made (2–4). However, the narrow time window is a huge challenge. It was reported that only 10–20% of patients with AIS could reach the hospital within 3 h in China (1). Other factors including hemorrhagic transformation, contraindications, and high healthcare costs, also limit the application rate of rt-PA and EVT. China Stroke Statistics 2019 reported that about 24% of eligible patients (<3% of all the patients) received rt-PA and 28.1% received EVT, which was much less than that in high-income countries (5, 6). Given the current situation, it is urgent to explore other remedial actions for patients with AIS.

More evidence suggest that the administration of antiplatelets is necessary for AIS treatment (7, 8). The Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial has demonstrated that dual-antiplatelet therapy combination clopidogrel with aspirin could reduce the early risk of stroke for transient ischemic attack and minor ischemic stroke (9). Moreover, the Acute Stroke or Transient Ischaemic Attack Treated with Ticagrelor and ASA [acetylsalicylic acid] for Prevention of Stroke and Death (THALES) trial also observed similar results by combining ticagrelor and aspirin (10). However, the current antiplatelet treatment cannot completely block all signaling pathways involved in platelet aggregation, leading to a potential possibility of new thrombosis after AIS (11).

Tirofiban is a fast-acting glycoprotein (GP) IIb-IIIa inhibitor with short half-life and could inhibit the final common pathway to platelet aggregation by reversibly blocking fibrin binding receptors (12). It has been approved for the treatment of myocardial revascularization (13). Several clinical trials on tirofiban have also been conducted in AIS. However, most of the data comes from the trials of tirofiban treatment in combination with rt-PA or EVT (14–17). These trials indicated that tirofiban in combination with rt-PA or EVT was associated with favorable functional outcomes at 3 months, and not associated with a higher rate of symptomatic intracranial hemorrhage (sICH). These findings suggest that the sequential application of tirofiban could improve the prognosis of stroke. Based on the previous clinical studies, we believe that tirofiban could be a promising drug for patients with AIS. However, no clinical trials are evaluating the use of tirofiban in patients who were not undergoing rt-PA or EVT therapy at the early stage.

The Efficacy and Safety of Tirofiban in Clinical Patients with acute Ischemic Stroke (ESCAPIST) trial was conducted to test the hypothesis that tirofiban with regular treatment would improve functional outcome, and would not increase the risk of sICH in patients with AIS within 12 h after symptom onset.

More at link.