Tests tenecteplase against standard drugs for mild acute ischemic stroke
Tests intravenous tenecteplase in adults with mild acute ischemic stroke within 4.5 hours.
Plain-language title generated from the registry record
Registry title: Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing Tiantan HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT06414499
- Record updated
- 24 July 2025
- Original description
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.Read full original descriptionShow less
TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial
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.
Inclusion: 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: Severe head trauma or previous stroke within 3 months；; Intracranial or spinal surgery within 3 months; Major surgery within 2 weeks; Use of thrombin inhibitors or factor Xa inhibitors within 48 hours; Participation in another clinical trial within 3 months prior to screening; Known allergic to rhTNK-tPA; History of intracranial hemorrhage; Gastrointestinal or urinary tract hemorrhage within 3 weeks；; Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma; Active visceral bleeding; Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure >180 mm Hg or diastolic >100 mm Hg; 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); Other severe illnesses with a life expectancy of less than six months; Acute bleeding tendency, including platelet count <100×10⁹/L or other clinically significant conditions; 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; Planned or likely acute endovascular treatments before randomization; NIHSS 1a > 2; Arterial puncture at a non-compressible site within 1 week；; Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；; Concomitantaortic arch dissection; Use of heparin within 24 hours; Large cerebral infarction on head CT or MRI (infarction area >1/3 of the middle cerebral artery territory); Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period; Deemed unsuitable for the study or at increased risk by the investigator's judgment.