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

Phase 3

Completed

• Conditions: Stroke
• Interventions: Drug: alteplase

• Registration Number: NCT02930837
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Study Start: 2016-11-15
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Results First Submitted: 2018-12-11
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
alteplase	alteplase	-

Primary Outcome Measures

Name	Time	Method
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	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.
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	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

Name	Time	Method
The Percentage of Patients With Death Related to Stroke or of Neurological Causes	90 days	The percentage of patients with death related to stroke or of neurological causes.
The Percentage of Patients With Severity of Adverse Events	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.
The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema	90 days	The percentage of patients with incidence of cerebral herniation and symptomatic edema.
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	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.
Patient Survival Probability at Visit 5 (Censoring at Day 90)	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.

Trial Locations

Locations (11)

Dongguan People's Hospital; 🇨🇳 Dongguan, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, China

Yanbian University Hospital; 🇨🇳 Yanji, China

Beijing Tiantan Hospital affiliated to Cap Med University; 🇨🇳 Beijing, China

First Hospital of Jilin University; 🇨🇳 Changchun, China

No.900 Hospital of PLA Joint Logistics Support Force; 🇨🇳 Fuzhou, China

Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, China

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China

Xuzhou Central Hospital; 🇨🇳 Xuzhou, China