NCT06954155

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND--A Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Intracranial Vessel Occlusion With Perfusion Mismatch 24 to 72 Hours of Symptom Onset

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Adult acute ischemic stroke patients due to middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA with baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function) will be enrolled in this trial. We use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio \>1.2, and mismatch volume \>10 mL). We will randomly assign patients who have salvageable brain tissue as identified on perfusion imaging to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 24 to 72 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Tenecteplase (0.25mg/kg)	Each vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds).
DRUG	Standard medical treatment	Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.

Timeline

• Start date: 2025-05-30
• Primary completion: 2027-02-28
• Completion: 2027-05-30
• First posted: 2025-05-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: China