Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-?(TRACE ?)

Phase 3

Recruiting

• Conditions: Tenecteplase; Minor Ischemic Stroke

• Registration Number: NCT06414499
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria<br><br> 1. Age = 18 years;<br><br> 2. Can be treated with study drug within 12 hours of symptoms onset*(*Symptom onset is<br> defined by the last seen normal principle);<br><br> 3. Clinical diagnosis of minor ischemic stroke (baseline NIHSS=5) with a measurable<br> neurological deficit defined as impairment of language or motor function;<br><br> 4. DWI/FLAIR mismatch on magnetic resonance imaging.<br><br> 5. Pre-stroke mRS 0-1;<br><br> 6. Informed consent signed.<br><br>Exclusion Criteria<br><br> 1. Contradictory or unable to complete MRI examination.<br><br> 2. Planned or likely acute endovascular treatments (any angioplasty or vascular<br> surgery);<br><br> 3. NIHSS 1a > 2;<br><br> 4. Known allergic to rhTNK-tPA;<br><br> 5. Known history of intracranial hemorrhage;<br><br> 6. Clinical stroke or serious head/spinal trauma within 3 months;<br><br> 7. Intracranial or spinal surgery within 3 months;<br><br> 8. Known history of gastrointestinal or urinary tract hemorrhage in the previous 21<br> days.<br><br> 9. Participants with a history of major surgery in the previous 14 days;<br><br> 10. Arterial puncture at a non-compressible site in the previous 7 days.<br><br> 11. Participants with intracranial tumors (excluding neuroectoderm origin, such as<br> meningioma), huge intracranial aneurysm, or arterio-venous malformation.<br><br> 12. Intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular<br> hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma)<br><br> 13. Participants with active visceral bleeding;<br><br> 14. Participants with aortic arch dissection;<br><br> 15. Participants with a known bleeding diathesis or with a platelet count < 100×109/L;<br><br> 16. Participants with a systolic blood pressure > 180 or a diastolic blood pressure ><br> 100 mmHg after repeated measurements and aggressive treatments;<br><br> 17. Blood glucose < 2.8 or > 22.2 mmol / L);<br><br> 18. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g.,<br> atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis);<br><br> 19. Receive intravenous thrombolysis within 24 hours;<br><br> 20. Receive direct oral anticoagulant therapy with international normalized ratio (INR)<br> > 1.7s or PT > 15 s;<br><br> 21. Receive low molecular weight heparin or heparinoid within 24 hours;<br><br> 22. Receive thrombin inhibitors or factor Xa inhibitors within 48 hours;<br><br> 23. Receive GP2b3a inhibitors within 72 hours;<br><br> 24. Participants who have large areas (greater than one third of middle cerebral artery<br> territory) of obvious low density on the baseline CT scan;<br><br> 25. Participants with a seizure at onset thought to be presenting with postictal<br> paralysis (Todd's paralysis) mimicking stroke.<br><br> 26. Participants with severe infection, such as bacterial endocarditis, pericarditis,<br> acute pancreatitis;<br><br> 27. Pregnant, currently trying to become pregnant, or of child-bearing potential and not<br> using birth control;<br><br> 28. Participation in another clinical study with an experimental product in the previous<br> 3 months;<br><br> 29. Participants deemed unsuitable for participation in this trial by the investigator<br> or those for whom participation in this trial may result in greater risks.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).

Secondary Outcome Measures

Name	Time	Method
Good functional outcome (mRS 0-2) at 90-day (± 7 days);Ordinal distribution of mRS scores at 90-day (± 7 days);NIHSS 0-1 at 24-hour, 7-day or discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased=2 from baseline);New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.;Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 36-hour, 7-day or discharge (analyze which occurs first).;Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 90-day (± 7 days);PH2 type intracranial hemorrhage according to the SITS criteria at 90-day (± 7 days);Any intracranial hemorrhage at 90-day (± 7 days);Moderate and severe bleeding events according to the GUSTO criteria at 90-day (± 7 days);Total mortality at 90-day (± 7 days);Adverse events/Severe adverse events reported by investigators at 90-day (± 7 days)