Health TrialsbyHealthPanel

Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYi Yang

About this trial

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old and ≤ 80 years old, regardless of gender;

Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset.

Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;

modified Rankin Scale (mRS) score of 1 or less before onset.

Disqualifiers

Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.

Transient ischemic attack (TIA);

Posterior circulation stroke;

Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Edaravone dexborneol

    Drug

    Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.

  • Placebo

    Drug

    Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Edaravone dexborneol groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

modified rankin scale (mRS) score ≤ 1

The proportion of patients with mRS score of 1 or less on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.

Time frame
Day 90 after randomization

Secondary outcomes

1

Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels

Time frame
Day 3 after randomization
2

Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels

Time frame
Day 7 after randomization
3

NIHSS score on day 7

NIHSS (National Institute of Health stroke scale) score on day 7 after randomization. NIHSS ranged from 0 to 42, a low value represents a better outcome.

Time frame
Day 7 after randomization
4

mRS score ≤ 2

The proportion of patients with an mRS score of 2 or less on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.

Time frame
Day 90 after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: