Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

Last updated: July 20, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Cerebral Ischemia

Cardiac Ischemia

Stroke

Treatment

Control group (Aspirin combined with clopidogrel)

Control group

Single/dual antiplatelet therapy

Clinical Study ID

NCT06414499
NCRC-2024-03
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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.

Study Design

Total Participants: 1386
Treatment Group(s): 4
Primary Treatment: Control group (Aspirin combined with clopidogrel)
Phase: 3
Study Start date:
July 09, 2025
Estimated Completion Date:
October 31, 2026

Study Description

This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. 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) will be enrolled. Eligible patients must have neurological deficits involving at least 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, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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