Tests tenecteplase clot-busting drug in adults with stroke from blocked brain arteries

Trial details

Who runs it

Beijing Tiantan Hospital

Trial code

NCT06954155

Record updated

1 April 2026

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: 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:; 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; target mismatch profile on CTP or MRI+PWI (ischemic core volume <70mL, mismatch ratio >1.2, and mismatch volume >10mL); 6)Written informed consent from patients or their legally authorized representatives.

Exclusion: 7)Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days; 10)Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm; 19)Participation in other interventional clinical trials within the previous 3 months; 2)Allergy to tenecteplase; 4)NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate; 11)Any terminal illness such that the patient would not be expected to survive more than 1 year; 14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI; 18)Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study; 6)Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable); 8)Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR >1.7 or prothrombin time >15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an aPTT greater than the upper limit of normal; 9)Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included); 1)Present as a significant low-density lesion on CT; 3)Rapidly improving symptoms at the discretion of the investigator; 5)Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment; 12)Unable to perform CTP or PWI; 13)Hypodensity in >1/3 MCA territory on non-contrast CT for MCA occlusion, and pc-ASPECTS <6 for BAO; 15)Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion); 16)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial; 17)Unlikely to adhere to the trial protocol or follow-up.

ClinicalTrials.gov NCT06954155