Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial
Beijing Tiantan Hospital
1,386 participants
Jul 9, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Age ≥ 18 years;
- Onset-to-treatment time < 4.5 h; onset time defined as "last known well" time;
- Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;
- Pre-stroke mRS 0-1;
- Informed consent signed.
Exclusion Criteria26
- Planned or likely acute endovascular treatments before randomization;
- NIHSS 1a > 2;
- Known allergic to rhTNK-tPA;
- History of intracranial hemorrhage;
- Severe head trauma or previous stroke within 3 months；
- Intracranial or spinal surgery within 3 months;
- Gastrointestinal or urinary tract hemorrhage within 3 weeks；
- Major surgery within 2 weeks;
- Arterial puncture at a non-compressible site within 1 week；
- Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；
- Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
- Active visceral bleeding;
- Concomitantaortic arch dissection;
- Acute bleeding tendency, including platelet count <100×10⁹/L or other clinically significant conditions;
- Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure >180 mm Hg or diastolic >100 mm Hg;
- Blood glucose < 2.8 or > 22.2 mmol / L;
- Prior anticoagulant therapy, such as oral warfarin, with an INR >1.7 or PT >15 seconds;
- Use of heparin within 24 hours;
- Use of thrombin inhibitors or factor Xa inhibitors within 48 hours;
- Large cerebral infarction on head CT or MRI (infarction area >1/3 of the middle cerebral artery territory);
- Todd's paralysis after a seizure or other neurological/psychiatric disorders affecting cooperation;
- Severe, uncontrolled infections (e.g., acute pericarditis, infective endocarditis, or acute pancreatitis);
- Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period;
- Participation in another clinical trial within 3 months prior to screening;
- Other severe illnesses with a life expectancy of less than six months;
- Deemed unsuitable for the study or at increased risk by the investigator's judgment.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06414499