Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III
China516 participantsStarted 2022-01-19
Plain-language summary
The trial is a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old;
✓. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
✓. Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
✓. Neuroimaging: target mismatch profile on CTP or MRI+MR Perfusion (ischemic core volume \<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
✓. Written informed consent from patients or their legally authorized representatives.
Exclusion criteria
✕. Intended to proceed to endovascular treatment;
✕. Allergy to tenecteplase;
✕. Rapidly improving symptoms at the discretion of the investigator;
✕. NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures ( Todd's palsy ) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate;
✕. Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable );
✕. Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days;
✕. Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an elevated aPTT greater than the upper limit of normal;