Overview
The trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. Participants with acute minor ischemic stroke (baseline NIHSS≤5) accompanied with measurable neurological deficit will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
Description
The study will be a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (2 arms with 1:1 randomization). 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) accompanied with measurable neurological deficit will be enrolled. The measurable neurological deficit is defined as impairment of 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. Control group (standard medical care): Single/dual antiplatelet therapy (aspirin, clopidogrel, ticagrelor, etc.) according to the guideline. The primary endpoint is excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day.
Eligibility
Inclusion Criteria
- Age ≥ 18 years;
- Can be treated with study drug within 4.5 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle);
- Clinical diagnosis of minor ischemic stroke (baseline NIHSS≤5) with a measurable neurological deficit defined as impairment of language or motor function;
- Pre-stroke mRS 0-1;
- Informed consent signed.
Exclusion Criteria
- Planned or likely to receive acute endovascular treatments (any angioplasty or vascular surgery);
- NIHSS 1a > 2;
- Known allergic to rhTNK-tPA;
- Known history of intracranial hemorrhage;
- Clinical stroke or serious head/spinal trauma within 3 months;
- Intracranial or spinal surgery within 3 months;
- Known history of gastrointestinal or urinary tract hemorrhage in the previous 21 days.
- Participants with a history of major surgery in the previous 14 days;
- Arterial puncture at a non-compressible site in the previous 7 days.
- Participants with intracranial tumors (excluding neuroectoderm origin, such as meningioma), huge intracranial aneurysm, or arterio-venous malformation.
- Intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma)
- Participants with active visceral bleeding;
- Participants with aortic arch dissection;
- Participants with a known bleeding diathesis or with a platelet count < 100×10^9/L;
- Participants with a systolic blood pressure ≥ 180 or a diastolic blood pressure ≥ 100 mmHg after repeated measurements and aggressive treatments;
- Blood glucose <50 or > 400 mg/dl (< 2.8 or > 22.2 mmol / l);
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis);
- Receive intravenous thrombolysis within 24 hours;
- Receive direct oral anticoagulant therapy with international normalized ratio (INR) > 1.7s or PT > 15 s;
- Receive low molecular weight heparin or heparinoid within 24 hours;
- Receive thrombin inhibitors or factor Xa inhibitors within 48 hours;
- Receive GP2b3a inhibitors within 72 hours;
- Participants who have large areas (greater than one third of middle cerebral artery territory) of obvious low density on the baseline CT scan;
- Participants with a seizure at onset thought to be presenting with postictal paralysis (Todd's paralysis) mimicking stroke.
- Participants with severe infection, such as bacterial endocarditis, pericarditis, acute pancreatitis;
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
- Participation in another clinical study with an experimental product in the previous 3 months;
- Participants deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.