The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) will be enrolled. Eligible patients must have neurological deficits involving at least language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,386
rhTNK-tPA 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy.
Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGExcellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).
Modified Rankin Scale score, mRS 0-1
Time frame: at 90-day (± 7 days)
Good functional outcome (mRS 0-2) at 90-day (± 7 days)
Time frame: at 90-day (± 7 days)
mRS score at 90-day (± 7 days)
shift analysis/ordinal distribution of mRS score at 90-day (±7 days)
Time frame: at 90-day (± 7 days)
COSMOS Scale 0-1 at 90-day (±7days)
Time frame: 90-day± 7days
COSMOS scale at 90-day (±7 days)
shift analysis/ordinal distribution of COSMOS scale at 90-day (±7 days)
Time frame: 90-day± 7days
NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥4 from baseline)
Time frame: at 24-hour, 7-day or before discharge (analyze which occurs first)
Neurological deterioration at 90 days
defined as an increase of ≥4 points in NIHSS score compared to baseline.
Time frame: 90-day (±7 days)
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.
Time frame: at 90-day (± 7 days)
European quality of life visual analogue scale at 90 days
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Time frame: at 90-day (± 7 days)
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 36-hour.
Time frame: within 36-hour
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 7 days or before discharge.
Time frame: within 7 days or before discharge
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
PH2 type intracranial hemorrhage according to the Heidelberg criteria within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Any intracranial hemorrhage within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Severe bleeding events according to the GUSTO criteria within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Total mortality within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Adverse events/Severe adverse events within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)