Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Recruiting now · Phase 3

Conditions studied: Stroke

In brief

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).

Key facts

Study ID

NCT06954155

Run by

Beijing Tiantan Hospital

People needed

330

Starts

2025-05-30

Expected to finish

2027-05-30

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 1)Present as a significant low-density lesion on CT
• 2)Allergy to tenecteplase
• 3)Rapidly improving symptoms at the discretion of the investigator
• 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
• 5)Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment
• 6)Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable)
• 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
• 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)
• 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
• 11)Any terminal illness such that the patient would not be expected to survive more than 1 year
• 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
• 14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI
• 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
• 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
• 19)Participation in other interventional clinical trials within the previous 3 months

Where it is running

• Beijing tiantan hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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