Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5

• Status: Recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting within 24 hours will be randomized 1:1 to intravenous tenecteplase (0.25mg/kg, maximum 25mg) ± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Tenecteplase; Tissue Plasminogen Activator

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.