Ischemic Stroke, Acute Clinical Trial
Official title:
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
The CHANCE-4 study is a multicenter, double-blind, double-simulation, randomized controlled study. In patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic intracranial artery stenosis within 24 hours of onset, we will examine whether treatment with tirofiban for 48 hours reduce the risk of ischemic stroke recurrence within 90 days compared with placebo.
The CHANCE-4 study is a multicenter, double-blind, double-simulation, randomized controlled study. In patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic intracranial artery stenosis within 24 hours of onset, we will examine whether treatment with tirofiban for 48 hours reduce the risk of ischemic stroke recurrence within 90 days compared with placebo. This study is blind to both researchers and subjects. A total of 4674 subjects will be expected to be enrolled, with 2337 in each group. The list of random codes will be generated centrally by an independent statistical team. The patient's medication will be packaged according to the random code table. During treatment, patients will receive the investigatory drug tirofiban or tirofiban placebo, assigned to the two groups with a 1:1 random probability. - Tirofiban treatment group: Patients will be given a load dose of Tirofiban (0.4μg/kg/min, total dose no more than 1mg) intravenously for 30 minutes within 24 hours of admission, and then will be maintained by intravenous micropump (0.1μg/kg/min) for 48 hours. - Tirofiban placebo group: Patients will be intravenously injected with Tirofiban placebo (0.9% normal saline) for 30 minutes within 24 hours of admission, and then will be maintained with intravenous micropump for 48 hours. The enrolled subjects will be interviewed face-to-face on the first day.And the final diagnosis, stroke etiological classification and related examination and treatment information during hospitalization will be recorded at discharge. Face-to-face interview will be conducted on the 90th ±7 day. And telephone interview will be conducted on the 12th month ±15 day. To evaluate whether Tirofiban, compared with placebo, can reduce the risk of ischemic stroke recurrence within 90 days in patients with acute mild ischemic stroke or TIA accompanied by symptomatic intracranial atherosclerotic stenosis within 24 hours of onset, providing evidence-based medical evidence for the secondary prevention of cerebrovascular diseases, and forming an intensive antiplatelet treatment regimen for ischemic cerebrovascular diseases and expert consensus. ;