Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke

Zhejiang University

Status: Enrolling

Conditions: Stroke

Treatments: Drug: Edaravone Dexborneol

Study type: Observational

Funder types: Other

Identifiers

NCT05121883

EDMETS

Details and patient eligibility

About

Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.

Full description

This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with anterior circulation acute ischemic stroke
• Patients aged between 18-80 years.
• CTA or DSA verified arterial occlusion of ICA, M1 or M2.
• NIHSS on admission 4 - 26
• Baseline CTP verified infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8
• Undergoing mechanical thrombectomy within 24 hours of stroke onset. For wake-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time

Exclusion criteria

• Patients without recanalization (TICI 0,1, 2a)
• Pre-existing neurological disability (a score greater than 2 on the mRS)
• Contraindication of edaravone dexborneol

Trial design

200 participants in 2 patient groups

Edaravone dexborneol group

Description:

Patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days will be classified into this group.

Treatment:

Drug: Edaravone Dexborneol

Standard medication group

Description:

Patients who do not recieve edaravone dexborneol will be classified into this group.