Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion (NCT05701956) | Clinical Trial Compass
CompletedPhase 3
Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion
China330 participantsStarted 2023-03-16
Plain-language summary
To assess the effect of intravenous tenecteplase plus endovascular thrombectomy (EVT) compared to EVT alone on 4.5 to 24 hours after stroke due to basilar artery occlusion.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;
✓. Time from stroke onset to randomization within 4.5-24 hours of estimated time of basilar artery occlusion;
✓. Patient's age≥18 years;
✓. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In cases of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
✓. Patients presenting with acute ischemic stroke eligible using standard criteria (except for time window) to receive both endovascular thrombectomy and intravenous thrombolysis;
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) score≥ 10 at the time of neuroimaging;
✓. The patient or patient's legal representative signs the informed consent form.
Exclusion criteria
✕. CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
✕. Pre-stroke modified Rankin scale (mRS) score of ≥ 2;
✕. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) \<5;
What they're measuring
1
Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days)
Timeframe: 90 (± 14 days) after procedure
Trial details
NCT IDNCT05701956
SponsorThe First Affiliated Hospital of University of Science and Technology of China