Clinical trial NCT05604638: Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
Official title: Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Lead sponsor: Second Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: CSPC Pharmaceutical Group Limited
First posted: 2022-11-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Detailed description: Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

Age 18-80 years Ischemic stroke with measurable deficit on NIH Stroke Scale Treatment within 4.5 hours of stroke onset Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1) Patients awakening with symptoms are defined by the time last observed normal Written informed consent by patient or proxy

Exclusion Criteria:

Patients with premorbid modified Rankin Scale (mRS) score ≥3 Patients for whom a complete NIH Stroke Score cannot be obtained Hemiplegic migraine with no arterial occlusion on CTA Seizure at stroke onset and no visible occlusion on baseline CTA Intracranial haemorrhage on baseline CT Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal Large areas of hypodense ischaemic changes on baseline CT Patients with systolic blood pressure \>185 mm Hg or diastolic blood pressure \>110 mm Hg Female, pregnant or breast feeding Known bleeding diathesis Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist Use of oral anticoagulants and International Normalized Ratio (INR) ≥1,4 Use of new oral anticoagulants (NOAC) within the last 12 hours Heparin \<48 hours and increased Activated partial thromboplastin tike (APTT) Low molecular weight heparin(oid) \<24 hours Any other investigational drug \<14 days Sepsis Patients with arterial puncture at a noncompressible site or lumbar puncture \<7 days Major surgery or serious trauma \<14 days Gastrointestinal or urinary tract hemorrhage \<14 days Clinical stroke \<2 months History of intracranial haemorrhage Brain neurosurgery \<2 months Serious head trauma \<2 months Pericarditis Any serious medical illness likely to interact with treatment Confounding pre-existent neurological or psychiatric disease Unlikely to complete follow-up Pregnancy

Primary outcomes:
measure: functional independence
timeFrame: 90 days
measure: mortality
timeFrame: 90 days
Secondary outcomes:
measure: excellent functional outcome
timeFrame: 90 days
measure: symptomatic intracranial hemorrhage
timeFrame: 48 hours
measure: any intracranial hemorrhage
timeFrame: 48 hours
Other outcomes:
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Study officials:
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