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Using Tenecteplase for Treating Acute Ischemic Stroke from Basilar Artery Occlusion

Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 Improving Neurological Functional Outcomes in Basilar Artery Occlusion With Tenecteplase in Extended Time Window: Multicentre, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial

PHASE3 · Beijing Tiantan Hospital · NCT06196320

This study is testing if a new treatment called tenecteplase can help people who have had a stroke caused by a blocked basilar artery feel better compared to standard care.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment452 (estimated)
Ages18 Years and up
SexAll
SponsorBeijing Tiantan Hospital (other)
Locations59 sites (Fuyang, Anhui and 58 other locations)
Trial IDNCT06196320 on ClinicalTrials.gov

What this trial studies

This multicenter, phase 3 trial investigates the efficacy of intravenous tenecteplase in patients with acute ischemic stroke caused by basilar artery occlusion. Participants will be randomized to receive either tenecteplase or standard care, which may include alteplase or no thrombolytic treatment, within 24 hours of symptom onset. The study aims to determine the effectiveness of tenecteplase in improving patient outcomes compared to existing treatment options. Patients will be monitored for clinical improvement and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion within 24 hours of symptom onset.

Not a fit: Patients with intracerebral hemorrhage, significant cerebellar mass effect, or other serious conditions identified by imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic strokes due to basilar artery occlusion.

How similar studies have performed: Previous studies have shown promising results with thrombolytic therapies in acute ischemic stroke, but the specific use of tenecteplase in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fuyang, Anhui and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ischemic Stroke, Acute, rhTNK-tPA, rt-PA, Ischemic stroke, phase III trial, basilar artery occlusion

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.