Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke
Authors: Zhao Wenbo , Li Sijie , Li Chuanhui , Wu Chuanjie , Wang Junmei , Xing Lifei , Wan Yue , Qin Jinhui , Xu Yaoming , Wang Ruixian , Wen Changming , Wang Aihua , Liu Lan , Wang Jing , Song Haiqing , Feng Wuwei , Ma Qingfeng , Ji Xunming ,   TREND Investigators, Ding Jianping , Wang Pingping , Wang Yuan , Hao Xiaojun , Bian Bujv , Feng Guanqing , Xie Yujia , Wen Hui , Yang Xinlin , Li Wenzhao , Gui Yuejiang , Hao Jing , Zhang Yaqiong , Zhao Qing , Yang Yang , Liu Rutao , Zhang Shanchao , Si Zhihui , Qiao Shan , Xu Shan , Yuan Jing , Shao Yajuan , Dai Fang , Zhang Guofeng , Huo Yanchao , Zhou Wenjing , Yang Lu , Cheng Xufei , Wang Min , Hou Haidong , Wang Haiying , Yan Hongliang , Fu Yajuan , Zang Bowen , Zhao Meiping , Wen Pingping , Lv Jianying , Lian Xiaojing , Kang Meijuan , Zhang Zaihang , Zhang Qing , Guo Zaiyu , Zhao Lianhua , Liu Xiaoliang , Zheng Jing , Ke Shangsheng , Shao Lin , Liu Xiaoyan , Tao Xiaoming , Ke Yingbing , Liu Hao , He Dandan 
Published: April 2024

Importance

Evidence supports using antiplatelet therapy in patients with acute ischemic stroke. However, neurological deterioration remains common under the currently recommended antiplatelet regimen, leading to poor clinical outcomes.

Objective

To determine whether intravenous tirofiban administered within 24 hours of stroke onset prevents early neurological deterioration in patients with acute noncardioembolic stroke compared with oral aspirin.

Design, Setting, and Participants

This investigator-initiated, multicenter, open-label, randomized clinical trial with blinded end-point assessment was conducted at 10 comprehensive stroke centers in China between September 2020 and March 2023. Eligible patients were aged 18 to 80 years with acute noncardioembolic stroke within 24 hours of onset and had a National Institutes of Health Stroke Scale (NIHSS) score of 4 to 20.

Intervention

Patients were assigned randomly (1:1) to receive intravenous tirofiban or oral aspirin for 72 hours using a central, web-based, computer-generated randomization schedule; all patients then received oral aspirin.

Main Outcome

The primary efficacy outcome was early neurological deterioration (increase in NIHSS score ≥4 points) within 72 hours after randomization. The primary safety outcome was symptomatic intracerebral hemorrhage within 72 hours after randomization.

Results

A total of 425 patients were included in the intravenous tirofiban (n = 213) or oral aspirin (n = 212) groups. Median (IQR) age was 64.0 years (56.0-71.0); 124 patients (29.2%) were female, and 301 (70.8%) were male. Early neurological deterioration occurred in 9 patients (4.2%) in the tirofiban group and 28 patients (13.2%) in the aspirin group (adjusted relative risk, 0.32; 95% CI, 0.16-0.65; P = .002). No patients in the tirofiban group experienced intracerebral hemorrhage. At 90-day follow-up, 3 patients (1.3%) in the tirofiban group and 3 (1.5%) in the aspirin group died (adjusted RR, 1.15; 95% CI, 0.27-8.54; P = .63), and the median (IQR) modified Rankin scale scores were 1.0 (0-1.25) and 1.0 (0-2), respectively (adjusted odds ratio, 1.28; 95% CI, 0.90-1.83; P = .17).

Conclusions and Relevance

In patients with noncardioembolic stroke who were seen within 24 hours of symptom onset, tirofiban decreased the risk of early neurological deterioration but did not increase the risk of symptomatic intracerebral hemorrhage or systematic bleeding.

Trial Registration

ClinicalTrials.gov Identifier: NCT04491695