This is a multicenter, double-blind, double-dummy, randomized clinical trial comparing the efficacy and safety of tirofiban versus placebo in preventing recurrence of stroke for patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events.
This is a multicenter, double-blind, double-dummy, randomized clinical trial to assess the effects of tirofiban versus placebo in preventing recurrence of stroke at 3-month in patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events. The participants will receive study medication of tirofiban or placebo within 24 hours of symptom onset by a randomization ratio of 1:1. For tirofiban group - Initial infusion of tirofiban 0.4μg/kg body weight/minute for 30 minutes (a maximum dose of 1mg) within 24 hours of symptom onset, followed by a continuous infusion of tirofiban 0.1μg/kg body weight/minute for 48 hours. For placebo group - Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours. The primary efficacy outcome is any new ischemic stroke at 3-month. The primary safety outcome is type 3 or 5 bleeding events according to the BARC criteria at 3-month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,674
Initial infusion of tirofiban 0.4μg/kg body weight/minute for 30 minutes (a maximum dose of 1mg) within 24 hours of symptom onset, followed by a continuous infusion of tirofiban 0.1μg/kg body weight/minute for 48 hours.
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGPeople's Hospital of Qihe County
Dezhou, Shandong, China
RECRUITINGLiaocheng People's Hospital(Liaocheng Brain Hospital)
Liaocheng, Shandong, China
Any new ischemic stroke at 3-month
Incidence of any new ischemic stroke at 3-month
Time frame: at 3-month
Type 3 or 5 bleeding events according to the BARC criteria at 3-month
Incidence of type 3 or 5 bleeding events according to the BARC criteria at 3-month
Time frame: at 3-month
Any new ischemic stroke within 1 year
Incidence of any new ischemic stroke within 1 year
Time frame: within 1 year
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.
Incidence of new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.
Time frame: Within 3 months after randomization and 1 year
Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year
Proportion of patients with disabling stroke (Modified Rankin Scale score, mRS\>1) at 3 months and 1 year. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Time frame: at 3 months and 1 year
Incidence and severity of recurrent stroke and TIA
Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year (Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke/severe non-fatal stroke \[mRS 4 or 5\]/moderate stroke \[mRS 2 or 3\]/mild stroke \[mRS 0 or 1\]/TIA/no stroke-TIA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Third People's Hospital of Liaocheng
Liaocheng, Shandong, China
RECRUITINGYantai Penglai traditional Chinese medicine hospital
Yantai, Shandong, China
RECRUITINGTime frame: Within 3 months after randomization and 1 year
Neurological impairment at 3 months (NIHSS increased≥4 from baseline ).
Proportion of patients with neurological impairment at 3 months ( National Institutes of Health Stroke Scale \[NIHSS\] score increased≥4 from baseline).
Time frame: at 3 months