Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium β¦ (NCT07469293) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)
China488 participantsStarted 2026-03-25
Plain-language summary
DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.
Who can participate
Age range18 Years β 100 Years
SexALL
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Inclusion criteria
β. Age β₯18 years old
β. Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours;
β. NlHSS score β₯ 5
β. CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction)
β. Patients with premorbid mRS 0 or 1
β. Written informed consent obtained from the participant or a legally authorized representative
Exclusion criteria
β. Intracranial hemorrhage confirmed by cranial CT or MRI;
β. Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours;