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

NCT02930837 | Completed Phase 3 Results

• 1 other identifier: 135.331
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 11

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  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.

  90 days

Secondary Outcomes (5)

• 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

• Patient Survival Probability at Visit 5 (Censoring at Day 90)

  90 days

• The Percentage of Patients With Death Related to Stroke or of Neurological Causes

  90 days

• 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 Incidence of Cerebral Herniation and Symptomatic Edema

  90 days

Study Arms (1)

alteplase

EXPERIMENTAL

Drug: alteplase

Interventions

alteplase DRUG

alteplase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (11)

Beijing Tiantan Hospital affiliated to Cap Med University

Beijing, 100050, China

Location

First Hospital of Jilin University

Changchun, 130031, China

Location

Dongguan People's Hospital

Dongguan, 523059, China

Location

No.900 Hospital of PLA Joint Logistics Support Force

Fuzhou, 350025, China

Location

Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510150, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, 510630, China

Location

General Hospital of Shenyang Military Region

Shenyang, 110015, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

Xuzhou Central Hospital

Xuzhou, 221009, China

Location

Yanbian University Hospital

Yanji, 133000, China

Location

Related Publications (1)

• 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.

  PMID: 32467323 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: November 15, 2016
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-08

Locations

CN (11)