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Extending the time window for Tenecteplase by Effective RecanalizatioN of bAsilar artery occLusion in patients with POSTerior circulation stroke
EU CTIS ID: 2024-513444-28-00
What this study is testing
The primary objective of the study is to test the hypothesis that the thrombolytic tenecteplase (TNK, 0.25mg/kg) administered within 24 hours after symptom onset ± thrombectomy, is superior to current best practice (alteplase, rtPA, 0.9mg/kg within 4.5 hours of stroke onset or standard care/no lysis ± thrombectomy) in achieving excellent functional outcome (mRS 0-1) or return to the premorbid modified Rankin Scale at 90 days in patients with acute ischaemic stroke due to basilar artery occlusion.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18
- Patient presenting with posterior circulation ischaemic 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.
- Presence of a basilar artery occlusion on CT Angiography or MR Angiography. Basilar artery occlusion will be 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).
- Affiliated to a French social security scheme or equivalent.
- Written informed consent obtained from the participant, from her/his next of kin or trusted person. Use of the emergency inclusion procedure if a next of kin or trusted person cannot be contacted. When a subject is no longer incapacitated, informed consent to continue participation will be obtained from the subject.
You likely can't join if
- Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
- Contraindication to imaging with contrast agents.
- Patient deprived of their liberty by judicial/administrative decision or subject to any legal protection measures (guardianship or trusteeship).
- Clinically evident pregnant woman.
- Current participation in another research drug treatment protocol.
- Known terminal illness such that the patients would not be expected to survive a year.
See the full eligibility criteria
- Age ≥18
- Patient presenting with posterior circulation ischaemic 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.
- Presence of a basilar artery occlusion on CT Angiography or MR Angiography. Basilar artery occlusion will be 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).
- Affiliated to a French social security scheme or equivalent.
- Written informed consent obtained from the participant, from her/his next of kin or trusted person. Use of the emergency inclusion procedure if a next of kin or trusted person cannot be contacted. When a subject is no longer incapacitated, informed consent to continue participation will be obtained from the subject.
- Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
- Contraindication to imaging with contrast agents.
- Patient deprived of their liberty by judicial/administrative decision or subject to any legal protection measures (guardianship or trusteeship).
- Clinically evident pregnant woman.
- Current participation in another research drug treatment protocol.
- Known terminal illness such that the patients would not be expected to survive a year.
- 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.
- Warfarin - thrombolysis can be used if point-of-care INR≤1.4 or laboratory INR≤1.7.
- Dabigatran – If dabigatran is known or suspected to have been taken within last 48 hours then Idarucizumab 5g IV bolus should be given prior to thrombolysis.
- Apixaban/Rivaroxaban - If Apixaban/Rivaroxaban is known to have been taken in last 12 hours then patient cannot be enrolled. If unclear, order urgent aPTT, INR, anti-Xa level: patient can be enrolled if appropriately calibrated anti-Xa level indicates <10 ng/mL apixaban or <100 ng/mL rivaroxaban.
- 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.
- Established frank hyperintensity on MRI FLAIR sequences indicating subacute infarction or presence of other unfavourable imaging profile which is likely to be associated with an increased risk of haemorrhagic transformation at the investigator’s discretion.
- Bilateral extensive brainstem ischaemia.
- 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.
- Other standard contraindications to intravenous thrombolysis.
- Contraindication to tenecteplase/alteplase (hypersensitivity to the active substance or to one of the excipients)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.