Trial intelligence / Profile preview

RAISE: Reteplase vs Alteplase in Acute Ischemic Stroke

NCT05295173Phase 3

Key facts

Status: Completed
Start: Mar 2022
Primary completion: Jun 2023
Countries: 1
Sponsor: China Resources Angde Biopharmaceutical
Modality: rProtein (Recombinant Protein), Biologic

Drugs: reteplase
Conditions: acute ischemic stroke (AIS)

Overview

Phase 3, randomised, open-label trial of reteplase in acute ischemic stroke (AIS) (2 arms), sponsored by China Resources Angde Biopharmaceutical. Primary endpoint: Functional handicap (Modified Rankin Scale) at 90 days. Started Mar 2022; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Reteplase
Reteplase 18mg + 18mg IV
Alteplase
Alteplase 0.9 mg/kg IV

Who it enrols

Patients aged 18-80 with Acute Ischemic Stroke within 4.5 hours of onset, NIHSS 4-25, without history of intracranial hemorrhage or severe bleeding risk.

Endpoints

Primary

Functional handicap (Modified Rankin Scale)90 days

Secondary

Proportion of Neurological Improvement7 days
Proportion of Long-term Improvement90 days
Ordinary distribution of mRS scores90 days
Barthel Index score90 days

Results

Primary endpoints met

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