💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria
1. Age ≥ 18 years;
2. Onset-to-treatment time \< 4.5 h; onset time defined as "last known well" time;
3. 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;
4. Pre-stroke mRS 0-1;
5. Informed consent signed.
Exclusion Criteria
1. Planned or likely acute endovascular treatments before randomization;
2. NIHSS 1a \> 2;
3. Known allergic to rhTNK-tPA;
4. History of intracranial hemorrhage;
5. Severe head trauma or previous stroke within 3 months；
6. Intracranial or spinal surgery within 3 months;
7. Gastrointestinal or urinary tract hemorrhage within 3 weeks；
8. Major surgery within 2 weeks;
9. Arterial puncture at a non-compressible site within 1 week；
10. Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；
11. Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
12. Active visceral bleeding;
13. Concomitantaortic arch dissection;
14. Acute bleeding tendency, including platelet count \<100×10⁹/L or other clinically significant conditions;
15. Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure \>180 mm Hg or diastolic \>100 mm Hg;
16. Blood glucose \< 2.8 or \> 22.2 mmol / L;
17. Prior anticoagulant therapy, such as oral warfarin, with an INR \>1.7 or PT \>15 seconds;
18. Use of heparin within 24 hours;
19. Use of thrombin inhibitors or factor Xa inhibitors within 48 hours;
20. Large cerebral infarction on head CT or MRI (infarction area \>1/3 of the middle cerebral artery territory);
21. Todd's paralysis after a seizure or other neurological/psychiatric disorders affecting cooperation;
22. Severe, uncontrolled infections (e.g., acute pericarditis, infective endocarditis, or acute pancreatitis);
23. Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period;
24. Participation in another clinical trial within 3 months prior to screening;
25. Other severe illnesses with a life expectancy of less than six months;
26. Deemed unsuitable for the study or at increased risk by the investigator's judgment.
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