evaluating the clinical effects of high-dose edaravone (Alsava) in patients with acute cerebral stroke who are eligible for treatment with recombinant tissue plasminogen activator (rtPA).

Evaluating the efficacy of high-dose edaravone (Alsava) administered within the first 48 hours of hospitalization on short-term outcomes (NIHSS score) and long-term outcomes (MRS score) in patients with acute ischemic stroke eligible for Altylase(rTPA) therapy, admitted within 4.5 hours of symptom onset.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240819062805N1

Enrollment

120

Registered

2024-11-06

Start date

2024-11-10

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke. Cerebral infarction, unspecified

Interventions

Intervention 1: In addition to receiving routine altilase treatment (biosimilar retplase from Arena Hayat Danesh Company), 2 vials of Alsava (20 mg/30 cc, biosimilar Edaravon from Zist Daro Danesh Com

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals aged over 20 years NIHSS score less than 4 accompanied by a disabling disorder. Admission should occur within 0 to 4.5 hours following the onset of symptoms. Administration of recombinant tissue plasminogen activator (rTPA)

Exclusion criteria

Exclusion criteria: History of Dementia History of a brain mass previous stroke History of Brain Trauma History of Brain Surgery Debilitating neurological and/or systemic disorders that resulted in a pre-admission MRS greater than 0. Renal and/or hepatic failure Decompensated heart failure that precludes the administration of intravenous fluids in the volume necessary for the study. History of Drug and Non-Drug Allergies History of any potential allergic reactions to sulfite-containing medications. pregnancy History of Seizures Patients eligible for mecanical thrombectomia

Design outcomes

Primary

Measure	Time frame
Functional outcome is assessed based on the National Institutes of Health Stroke Scale (NIHSS) score and the Modified Rankin Scale (MRS) score. Timepoint: NIHSS score recorded three days post-hospitalization; MRS score assessed three months following discharge. Method of measurement: The standard forms for the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojdeh Ghabaee

Tehran University of Medical Sciences

Mojdeh.ghabaee@gmail.com+98 21 6694 8899

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026