Phase 3 N=120 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02930837 ↗

Enrolled (actual)

120

Serious AEs

10.0%

Results posted

Aug 2019

Primary outcome: Primary: 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 — 42.5; 20.8; 8.3; 14.2 Percentage of patients — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: alteplase (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	42.5; 20.8; 8.3; 14.2; 1.7; 7.5	<0.0001 sig
PRIMARY 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	2.5; 0.0; 0.0; 0.0; 0.0	—
SECONDARY 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	55.0; 63.3; 65.8; 56.7; 69.2	—
SECONDARY Patient Survival Probability at Visit 5 (Censoring at Day 90)	0.0; 3.3; 1.7; 0.0	—
SECONDARY The Percentage of Patients With Death Related to Stroke or of Neurological Causes	4.2	—
SECONDARY The Percentage of Patients With Severity of Adverse Events	85.8; 20.8; 12.5; 0.0; 10.0; 4.2	—
SECONDARY The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema	4.2	—

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 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 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

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Data sourced from ClinicalTrials.gov (NCT02930837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.