Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND
The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical trea
| Condition(s) | Stroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke). |
| Who can participate | Inclusion Criteria: * 1)Age ≥ 18 years old; * 2)Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time'; * 3)Pre-stroke modified Rankin scale (mRS) score ≤1; * 4)Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function); * 5)Neuroimaging: 1. Middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA, being responsible for signs and symptoms of acute ischemic stroke; 2. target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio \>1.2, and mismatch volume \>10mL); * 6)Written informed co |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Beijing Tiantan Hospital |
| Locations | Beijing, China |
| Start date | 2025-05-30 |
| NCT ID | NCT06954155 |
| Official listing | https://clinicaltrials.gov/study/NCT06954155 |