Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5

Launched by BEIJING TIANTAN HOSPITAL · Jan 7, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5, is studying a treatment for patients who have had an ischemic stroke caused by a blockage in the basilar artery. The study aims to compare a new medication called tenecteplase, given through an IV, to standard treatments like alteplase or no clot-busting therapy at all, to see which is more effective in helping patients recover. The trial is open to adults aged 18 and older who show specific symptoms of a stroke and have a confirmed blockage in the basilar artery within 24 hours of symptom onset.

Eligible participants can expect to be randomly assigned to one of the treatment groups and will be monitored closely throughout the study. It's important to note that certain conditions, like having severe bleeding in the brain or significant prior disability, would exclude someone from participating. The trial is currently recruiting patients, and those interested should discuss with their healthcare provider to see if they qualify. This study could help improve treatment options for future patients experiencing similar strokes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18.
• • 2. Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well.
• • 3. Presence of a basilar artery occlusion, proven by CT Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a partial or complete occlusion.
• • 4. Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
• • 5. Local legal requirements for consent have been satisfied.
• Exclusion Criteria:
• • 1. Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
• • 2. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6.
• • 3. Significant cerebellar mass effect or acute hydrocephalus.
• • 4. Established frank hypodensity on non-contrast CT indicating subacute infarction.
• • 5. Bilateral extensive brainstem ischemia.
• • 6. Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
• • 7. Other standard contraindications to intravenous thrombolysis.
• • 8. Contraindication to imaging with contrast agents.
• • 9. Clinically evident pregnant women.
• • 10. Vessel imaging showing both anterior and posterior circulation large vessel occlusion.
• • 11. Current participation in another research drug treatment protocol.
• • 12. Known terminal illness such that the patients would not be expected to survive a year.
• • 13. Planned withdrawal of care or comfort care measures.
• • 14. 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.