Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Registration Number
- NCT05604638
- Lead Sponsor
- Second Affiliated Hospital of Guangxi Medical University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tenecteplase plus Tirofiban Tenecteplase plus Tirofiban Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \~10 seconds). Patients will receive a continuous intravenous infusion of tirofiban at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis . Tenecteplase plus Placebo Tenecteplase plus Placebo Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \~10 seconds). Patients will receive a continuous intravenous infusion of placebo at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min, if there was no parenchymal hemorrhage or extensive subarachnoid hemorrhage beyond the Sylvian fissure on the posttreatment computed tomography scan. Aspirin (100 mg/d) will be given orally at 4 hours before the end of infusion and continued for at least 3 months after intravenous thrombolysis .
- Primary Outcome Measures
Name Time Method mortality 90 days mRS score, 6
functional independence 90 days mRS score, 0-2
- Secondary Outcome Measures
Name Time Method excellent functional outcome 90 days mRS score, 0-1
any intracranial hemorrhage 48 hours symptomatic intracranial hemorrhage 48 hours