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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

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ClinicalTrials.gov Identifier: NCT02930837
Recruitment Status : Completed
First Posted : October 12, 2016
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment Phase
Stroke Drug: alteplase Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arms and Interventions
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Arm Intervention/treatment
Experimental: alteplase Drug: alteplase


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 90 days ]
    The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead.

  2. 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 [ Time Frame: 90 days ]
    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. According to the protocol, sICH (ECASS III criteria) was defined as: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration (defined by an increase in the NIHSS score of 4 or more points), or that led to death and that was identified as the predominant cause of the neurological deterioration. sICH event was firstly evaluated by investigator. The DMC consultants evaluated all the patients with NIHSS score increase of at least 4 any time after treatment (including all fatal patients and sICH events evaluated by investigator). Wilson score confidence interval is presented.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 90 days ]
    Percentage of global outcome responder at day 90 if he/she obtains the following results at day 90 for the endpoints mRS score of 0 to 1; Barthel Index score >= 95; NIHSS score of 0 to 1; Glasgow Outcome Scale score of 1. mRS: 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. NIHSS is composed of 11 items, and for each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Glasgow Outcome Score applies to patients with brain damage allowing the objective assessment of their recovery in five categories: 1 Good Recovery, 2 Moderately Disabled, 3 Severely Disabled, 4 Vegetative State, 5 Dead. Barthel Index score to measure performance in activities of daily living with the scale ranging from 0 to 100. Global outcome response is the intersection of above four respective outcomes.

  2. Patient Survival Probability at Visit 5 (Censoring at Day 90) [ Time Frame: 90 days ]
    Patient survival probability at visit 5 (censoring at day 90). The percentage of patients who died until Day 1, Day 7, Day 30, Day 90.

  3. The Percentage of Patients With Death Related to Stroke or of Neurological Causes [ Time Frame: 90 days ]
    The percentage of patients with death related to stroke or of neurological causes.

  4. The Percentage of Patients With Severity of Adverse Events [ Time Frame: On-treatment period, that is, within 7 days from the start of bolus ]
    The percentage of patients with severity of adverse events (AEs). The percentage of patients with different categories of AEs are presented.

  5. The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema [ Time Frame: 90 days ]
    The percentage of patients with incidence of cerebral herniation and symptomatic edema.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930837


Locations
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China
Beijing Tiantan Hospital affiliated to Cap Med University
Beijing, China, 100050
First Hospital of Jilin University
Changchun, China, 130031
Dongguan People's Hospital
Dongguan, China, 523059
No.900 Hospital of PLA Joint Logistics Support Force
Fuzhou, China, 350025
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510150
The First Affiliated Hospital of Jinan University
Guangzhou, China, 510630
General Hospital of Shenyang Military Region
Shenyang, China, 110015
Tianjin Medical University General Hospital
Tianjin, China, 300052
Renmin Hospital of Wuhan University
Wuhan, China, 430060
Xuzhou Central Hospital
Xuzhou, China, 221009
Yanbian University Hospital
Yanji, China, 133000
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] February 15, 2017
Statistical Analysis Plan  [PDF] August 23, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02930837    
Other Study ID Numbers: 135.331
First Posted: October 12, 2016    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action