drugset / Trial / NCT07119021
Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
Phase 4
Recruiting
300 enrolled
Ruijun Ji
Nanjing Baixinyu Pharmaceutical Co., Ltd. · collabNanyang nanshi Hospital · collabSuzhou First People's Hospital · collabXing'an League People's Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
EXCELLENT was a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study in which participants were randomized participants were randomized (1:1) to receive either IV thrombolysis + edaravone or IV thrombolysis + matched placebo (same volume of tablets without drug components), and the primary outcome was the proportion of patients with transformed bleeding on MRI at 72 hours following revascularization therapy.
Timeline
- Start
- 2024-08-01
- Primary completion
- 2027-04-30
- Completion
- 2027-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Edaravone | Unknown | — | Subcutaneous |
| Background | t-PA | Unknown | 0.9 mg/kg | Intravenous |
| Background | t-PA | Unknown | 0.9 mg/kg | Intravenous |