Tenecteplase treatment for minor ischemic strokes

TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial

This study is testing if a new treatment called tenecteplase can help people who have had minor strokes recover better than those who receive standard care.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1386 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06414499 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of tenecteplase, a thrombolytic agent, in patients experiencing acute minor ischemic strokes with specific imaging criteria. Participants will be randomly assigned to receive either tenecteplase or standard medical treatment within 12 hours of symptom onset. The study aims to determine if tenecteplase can improve functional outcomes at 90 days, as measured by the Modified Rankin Scale. It is a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of minor ischemic stroke and specific imaging findings.

Not a fit: Patients with contraindications to MRI or those requiring acute endovascular treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with minor ischemic strokes.

How similar studies have performed: Previous studies have shown promise with thrombolytic therapies in stroke management, but this specific approach with tenecteplase in minor strokes is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Yongjun Wang, MD, PhD

Conditions Minor Ischemic Stroke; minor stroke; tenecteplase