drugset / Trial / NCT05295173
A Study of r-PA Treating Patients With Acute Ischemic Stroke(RAISE)
Phase 3
Completed
1412 enrolled
Angde Biotech Pharmaceutical Co., Ltd.
Beijing Tiantan Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of recombinant human tissue plasminogen kinase derivatives for injection and alteplase in the treatment of patients with acute ischemic stroke within 4.5 hours.
Timeline
- Start
- 2022-03-21
- Primary completion
- 2023-06-22
- Completion
- 2023-06-22
Outcome
Met primary endpoint
paper Among patients with ischemic stroke within 4.5 hours after symptom onset, reteplase was more likely to result in an excellent functional outcome than alteplase. PMID 38884332 ↗
Publications
- Wang J, He D, Gu H, Li Z, Wang Y, Zhao X, Wang Y, Li S. Efficacy and Safety of Reteplase Versus Alteplase in Acute Ischemic Stroke Based on Fibrinogen Levels: The RAISE Trial Subgroup. J Am Heart Assoc. 2026 May 19;15(10):e047832. doi: 10.1161/JAHA.125.047832. Epub 2026 May 6.
- Wang X, Feng B, Gu HQ, Li Z, Wang Y, Zhao X, Li S, Wang Y. Outcomes of Time to Treatment With Reteplase for Acute Ischemic Stroke: The RAISE Trial Subgroup. JACC Asia. 2025 Apr;5(4):584-592. doi: 10.1016/j.jacasi.2024.12.010. Epub 2025 Feb 11.
- Li S, Gu HQ, Li H, Wang X, Jin A, Guo S, Lu G, Che F, Wang W, Wei Y, Wang Y, Li Z, Meng X, Zhao X, Liu L, Wang Y; RAISE Investigators. Reteplase versus Alteplase for Acute Ischemic Stroke. N Engl J Med. 2024 Jun 27;390(24):2264-2273. doi: 10.1056/NEJMoa2400314. Epub 2024 Jun 14.
- Li S, Gu HQ, Dai H, Lu G, Wang Y. Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial. Stroke Vasc Neurol. 2024 Nov 5;9(5):568-573. doi: 10.1136/svn-2023-003035.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alteplase | Protein / enzyme biologic | 0.9 mg/kg | Intravenous |
| Subject | reteplase | Protein / enzyme biologic | 18 mg | Intravenous |