Extending treatment options for stroke caused by basilar artery blockage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of tenecteplase, a thrombolytic agent, in patients experiencing acute ischemic stroke due to basilar artery occlusion. Patients will be randomly assigned to receive either standard care or tenecteplase before undergoing mechanical thrombectomy if necessary. The study employs a Multi-Arm Multi-Stage design with adaptive sample size adjustments based on interim results, focusing on recanalization rates and functional outcomes at three months. The trial aims to determine if extending the treatment window for tenecteplase can improve patient outcomes in this critical condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Patient's age is ≥18 years
* Presence of basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion is defined as 'potentially retrievable' occlusion at the basilar artery. This can be a partial or complete occlusion.
* Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
* Local legal requirements for consent have been satisfied.

Exclusion Criteria:

* Intracerebral hemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
* Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \<7 on non-contrast CT, CT Angiography source images or DWI MRI.
* Significant cerebellar mass effect or acute hydrocephalus.
* Established frank hypodensity on non-contrast CT indicating subacute infarction.
* Bilateral extensive brainstem ischemia.
* Strong suspicion of underlying intracranial atherosclerotic disease (e.g diffuse arterial calcifications, basilar stenosis) or dissection which may require immediate neuro-interventional procedure with intracranial stenting and not benefit from intravenous thrombolysis at investigator's discretion.
* Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
* Other standard contraindications to intravenous thrombolysis.
* Contraindication to imaging with contrast agents.
* Clinically evident pregnant women.
* Current participation in another research drug treatment protocol.
* Known terminal illness such that the patients would not be expected to survive a year.
* Planned withdrawal of care or comfort care measures.
* 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 it's running

• Liverpool Hospital
  Sydney, New South Wales, Australia Recruiting
• Princess Alexandra Hospital
  Woolloongabba, Queensland, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting
• Alfred Health
  Melbourne, Victoria, Australia Recruiting
• Austin Hospital
  Melbourne, Victoria, Australia Recruiting
• Box Hill Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Bruce Campbell — University of Melbourne
• Study coordinator: Fana Alemseged, MD, PhD
• Email: Fana.Alemseged@unimelb.edu.au
• Phone: +6193424424

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endovascular Therapy for Basilar Artery Occlusion With Large Ischemic Core

  This trial tests whether adding endovascular therapy to standard medical care helps people with acute basilar artery occlusion and a large area of brain already affected.

  Recruiting The First Affiliated Hospital of University of Science and Technology of China · Hefei, Anhui · NCT07672795

• Basilar artery occlusion with large brain infarct: real-world endovascular vs medical therapy

  This registry follows adults with basilar artery occlusion and a large core infarct to see how endovascular therapy compares to medical management in routine care.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07345702

• Tenecteplase before transfer for basilar artery stroke 4.5–24 hours after symptom onset

  This trial tests whether giving IV tenecteplase before transfer helps people with basilar artery occlusion who are 4.5–24 hours from symptom onset and are being sent for thrombectomy.

  Recruiting Phase 4 Xuanwu Hospital, Beijing · Beijing · NCT07203625

• Endovascular treatment for acute basilar artery stroke with a large infarct core

  This trial will test whether adding endovascular clot removal to standard medical care helps adults with acute basilar artery occlusion who already have a large area of brain damage.

  Recruiting at 2 sites The First Affiliated Hospital of Hainan Medical University · Hefei, Anhui and 1 other locations · NCT07090941

• Rescue treatment for mild ischemic stroke with basilar artery blockage

  This study is testing if combining a new type of treatment with standard care can help people with mild strokes caused by a blocked basilar artery feel better and recover more effectively.

  Recruiting at 2 sites First Affiliated Hospital of Wannan Medical College · Hefei, Anhui and 1 other locations · NCT06843356

• Comparing two methods for treating stroke caused by basilar artery blockage

  This study is testing two different methods for removing blood clots in the brain to see which one helps adults with stroke caused by a blocked basilar artery recover better.

  Recruiting at 4 sites Hopital Foch · Bordeaux and 11 other locations · NCT05320263

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.