Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.
(1)Age≥18 years old;
(2)Acute ischemic stroke symptom onset within 4.5 - 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
(3)Primary medium vessel occlusions confirmed by CTA/MRA, including distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
(4)Neuroimaging criteria: a) Perfusion criteria:Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume <70mL, mismatch ratio >1.2, mismatch volume >10mL); b) If neither MRI or CT perfusion is available at the site : an Alberta Stroke Program Early CT Score [ASPECTS] of 8 or more on NCCT /MRI-DWI or PC-ASPECTS of 8 or more on NCCT/MRI-DWI.
(1)Allergy to tenecteplase;
(2)Rapidly improving symptoms at the discretion of the investigator;
(3)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;
(4)Intention to undergo endovascular treatment.
Parallel
Tenecteplase (0.25mg/kg)
DrugEach vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds).
Standard medical treatment
DrugAspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
mRS score ≤ 1 at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days
mRS score
Ordinal distribution of mRS at 90 days (shift analysis)
mRS score ≤ 2
The proportion of patients with an mRS score of 0-2 at 90 days
Early neurological improvement
The rate of early neurological improvement at 24h after randomization (defined as a NIHSS score ≤1 or ≥4 points compared with the baseline)
mRS 5-6
mRS 5-6 at 90 days
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Beijing Tiantan Hospital
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
Chinese Stroke Association
Collaborator
