NCT06414499 Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
| NCT ID | NCT06414499 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Minor Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,386 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,386 participants in total. It began in 2025-07-09 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Yongjun Wang, MD, PhD
STUDY DIRECTOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT06414499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Minor Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06414499 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,386 participants.
Is NCT06414499 currently recruiting?
Yes, NCT06414499 is actively recruiting participants. Contact the research team at yongjunwang@ncrcnd.org.cn for enrollment information.
Where is the NCT06414499 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06414499 clinical trial?
NCT06414499 is sponsored by Beijing Tiantan Hospital. The principal investigator is Yongjun Wang, MD, PhD at Beijing Tiantan Hospital. The trial plans to enroll 1,386 participants.
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