Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset
Stroke
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion criteria:
Age >= 18 years at screening(visit 1A) but <= 80 years Signed and dated written informed consent in accordance with good clinical practice and local legislation prior to admission to the trial Diagnosis of ischemic stroke with a measureable neurological deficit on National Institute of Health Stroke Scale (NIHSS) Thrombolytic therapy can be initiated within 3 to 4.5 hours of stroke onset Further inclusion criteria apply
Exclusion criteria:
Evidence of intracranial haemorrhage (ICH) on the (Computer Tomography) CT/(Magnetic Resonance Imaging)MRI-scan or symptoms suggestive of subarachnoid haemorrhage, even if the CT/MRI-scan is normal Acute bleeding diathesis Severe stroke as assessed clinically( e.g. National Institute of Health Stroke Scale>25) and/ or imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere) Severe uncontrolled arterial hypertension, e.g. systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg, or aggressive management (intravenous medication) necessary to reduce blood pressure to these limits Blood glucose <50mg/ dL or >400 mg/dL Any history of prior stroke in previous 3 months, or any history of prior stroke with concomitant diabetes Seizure at stroke onset Further exclusion criteria apply
Sites / Locations
- Beijing Tiantan Hospital affiliated to Cap Med University
- First Hospital of Jilin University
- Dongguan People's Hospital
- No.900 Hospital of PLA Joint Logistics Support Force
- Third Affiliated Hospital of Guangzhou Medical University
- The First Affiliated Hospital of Jinan University
- General Hospital of Shenyang Military Region
- Tianjin Medical University General Hospital
- Renmin Hospital of Wuhan University
- Xuzhou Central Hospital
- Yanbian University Hospital
Arms of the Study
Arm 1
Experimental
alteplase