Clinical trial NCT02930837: 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
Official title: An Open Label, Multicenter, Single-arm Trial to Assess Safety and Efficacy of Alteplase (Rt-PA) in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours after onset of stroke symptoms in Chinese patients with acute ischemic 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

Primary outcomes:
measure: The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
timeFrame: 90 days
measure: The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
timeFrame: 90 days
Secondary outcomes:
measure: The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
timeFrame: 90 days
measure: Patient Survival Probability at Visit 5 (Censoring at Day 90)
timeFrame: 90 days
measure: The Percentage of Patients With Death Related to Stroke or of Neurological Causes
timeFrame: 90 days
measure: The Percentage of Patients With Severity of Adverse Events
timeFrame: On-treatment period, that is, within 7 days from the start of bolus
measure: The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital affiliated to Cap Med University
city: Changchun
country: China
facility: First Hospital of Jilin University
city: Dongguan
country: China
facility: Dongguan People's Hospital
city: Fuzhou
country: China
facility: No.900 Hospital of PLA Joint Logistics Support Force
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
city: Yanji
country: China
facility: Yanbian University Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Zheng H, Yang Y, Chen H, Li C, Chen Y, Shi FD, Yang L, Cui X, Lu Z, Liang Y, Cui S, Xu A, Wu Y, Sun Y, Wang Y. Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: the first multicentre, phase III trial in China. Stroke Vasc Neurol. 2020 Sep;5(3):285-290. doi: 10.1136/svn-2020-000337. Epub 2020 May 28.