Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Launched by BEIJING TIANTAN HOSPITAL · Apr 24, 2025

Keywords

ClinConnect Summary

The BEYOND trial is a study that aims to investigate the use of a medication called tenecteplase for treating strokes caused by blood clots, specifically in patients who have had symptoms for 24 to 72 hours. This is important because most stroke treatments are typically given within a much shorter time frame. In this trial, researchers want to see if tenecteplase can safely help patients who fall outside the usual treatment window and if it works better than standard care for strokes linked to large blood vessel blockages.

To participate in this study, individuals must be at least 18 years old and have experienced a stroke within the specified time frame. They should also have mild to moderate stroke-related symptoms and meet specific medical imaging criteria that confirm the type of stroke. Participants will receive either tenecteplase or standard treatment, and the trial will monitor their health and recovery closely. It's essential for potential participants to understand the eligibility criteria and that informed consent is required to ensure they are comfortable with the study before joining.

Gender

ALL

Eligibility criteria

• 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);
• 5. Neuroimaging:
• • 1. Middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA, middle cerebral artery M1 or M2 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 ≥1.8, and mismatch volume ≥15mL);
• • 6. Written informed consent from patients or their legally authorized representatives.
• Exclusion Criteria:
• • 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
• • 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