NCT06587347

Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke

Effects of Tirofiban on Early Neurological Deterioration After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: an Open-label, Multicenter, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke.

Detailed description

Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA), administered within 4.5 hours of symptom onset, remains the standard treatment strategy for acute ischemic stroke. However, approximately 6-40% of patients experienced early neurological deterioration following intravenous thrombolysis, among which more than 70% resulted from ischemic events, with 20-34% due to early re-occlusion of the recanalized artery. Augmented platelet activation, triggered by the activated coagulation cascade and endothelial injury during rt-PA administration, is recognized as one of the primary reasons for ischemic events after intravenous thrombolysis. Early antiplatelet therapy following rt-PA effectively reduces neurological deterioration and improves functional outcomes. However, the current guidelines recommend that antiplatelet therapy should be initiated 24 hours after intravenous thrombolysis due to the potential risk of intracerebral hemorrhage. Tirofiban, a glycoprotein (GP) IIb/IIIa receptor inhibitor renowned for its rapid action, high selectivity, and short half-life, has been found to exert a remarkable antiplatelet effect by effectively blocking the terminal pathway that triggers platelet aggregation. One recent randomized trial found that among patients with acute non-cardioembolic ischemic stroke who presented within 24 hours of symptom onset, intravenous tirofiban resulted in a lower likelihood of early neurological deterioration than oral aspirin, without increasing the risk of intracranial hemorrhage or systematic bleeding. Another randomized trial found that treatment with intravenous tirofiban administration was safe and significantly improved 3-month functional outcomes in patients who experienced early neurological deterioration or no improvement within 24 hours of intravenous thrombolysis, compared with aspirin. Furthermore, our previous study found that early administration of tirofiban in patients with early neurological deterioration within the first 24 hours of intravenous thrombolysis did not increase the risk of symptomatic intracerebral hemorrhage, any intracerebral hemorrhage, or mortality. In contrast, it was associated with neurological improvement at 3 months. However, whether early administration of tirofiban can safely and effectively prevent neurological deterioration in patients with acute ischemic stroke treated with intravenous thrombolysis within 24 hours remains unclear, while the subset of patients who may benefit from early antiplatelet therapy.

Conditions

• Acute Stroke
• Ischemic Stroke, Acute
• Cerebral Infarction

Interventions

Type	Name	Description
DRUG	Tirofiban Hydrochloride	Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion until 24 hours after Intravenous thrombolytic therapy, or use a loading dose, 25 μg/kg, administrated within 3 minutes, then 0.15μg/kg/min infusion until 24 hours after Intravenous thrombolytic therapy.
DRUG	Standard medical treatment (SMT)	Patients will receive standard antiplatelet therapy.

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-09-19
• Last updated: 2024-10-29

Locations

1 site across 1 country: China