Clinical trial NCT04984577: Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
Official title: Phase II Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Nanjing Yoko Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients, diagnosed of ischemic stroke;
* Onset of stroke is less than or equal to 48 hours;
* There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
* Patients signed written inform consent

Exclusion Criteria:

* Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
* Iatrogenic stroke;
* Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
* The mRS score prior to this onset is greater than 1;
* Transient ischemic attack (TIA);
* SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
* Patients with severe mental disorders and dementia;
* ALT or AST is greater than 2.0×ULN; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min;
* Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
* Thrombectomy or interventional therapy has been applied or planned after this onset;
* Patients with malignant tumors or receiving concurrent antitumor treatment;
* Patients with severe systemic disease, life expectancy is less than 90 days;
* Allergic to edaravone , taurine or related excipients;
* Pregnant or lactating women;
* Have major surgery within 4 weeks before enrollment and not recovered enough to start the study;
* Participated in other clinical studies within 30 days before randomization;
* The investigators consider the patients are not suitable for this trial.

Primary outcomes:
measure: The proportion of patients with mRS ≤1 on day 90
timeFrame: day 90
Secondary outcomes:
measure: Changes of NIHSS score from baseline on day 14
timeFrame: day 14
measure: The proportion of patients with mRS ≤2 on day 90
timeFrame: day 90
measure: The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
timeFrame: day 14, 30, 90
measure: The proportion of patients with ADL-BI ≥95 on day 14, 30, 90
timeFrame: day 14, 30, 90
measure: EQ-5D score on day 90
timeFrame: day 90
measure: Ordinal Distribution of mRS on day 90
timeFrame: day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital，Capital Medical University
Study officials:
References: