Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Minor Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT06414499

Run by

Beijing Tiantan Hospital

People needed

1386

Starts

2025-07-09

Expected to finish

2026-10-31

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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