Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
China452 participantsStarted 2024-01-24
Plain-language 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) Ā± thrombectomy or 'best practice'which may be alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) Ā± thrombectomy at treating clinician's discretion.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age ā„18.
ā. Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete 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.
ā. Presence of a basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near or complete occlusion.
ā. Premorbid mRS ā¤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
ā. Local legal requirements for consent have been satisfied.
Exclusion criteria
ā. Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
ā. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) \<6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI).
ā. Significant cerebellar mass effect or acute hydrocephalus.
ā. Established frank hypodensity on non-contrast CT indicating subacute infarction.
ā. Bilateral extensive brainstem ischemia.
ā. Pre-stroke mRS of ā„4 (indicating moderate to severe previous disability).
What they're measuring
1
Modified Rankin Scale (mRS) 0-1 or return to baseline mRS