Minor Ischemic Stroke Clinical Trial
Official title:
TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Multicenter, Prospective, Open Label, Blinded-endpoint, Randomized Controlled Trial
The trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. Participants with acute minor ischemic stroke (baseline NIHSS≤5) accompanied with measurable neurological deficit will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
| Status | Recruiting |
| Enrollment | 1874 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | July 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria 1. Age = 18 years; 2. Can be treated with study drug within 4.5 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle); 3. Clinical diagnosis of minor ischemic stroke (baseline NIHSS=5) with a measurable neurological deficit defined as impairment of language or motor function; 4. Pre-stroke mRS 0-1; 5. Informed consent signed. Exclusion Criteria 1. Planned or likely to receive acute endovascular treatments (any angioplasty or vascular surgery); 2. NIHSS 1a > 2; 3. Known allergic to rhTNK-tPA; 4. Known history of intracranial hemorrhage; 5. Clinical stroke or serious head/spinal trauma within 3 months; 6. Intracranial or spinal surgery within 3 months; 7. Known history of gastrointestinal or urinary tract hemorrhage in the previous 21 days. 8. Participants with a history of major surgery in the previous 14 days; 9. Arterial puncture at a non-compressible site in the previous 7 days. 10. Participants with intracranial tumors (excluding neuroectoderm origin, such as meningioma), huge intracranial aneurysm, or arterio-venous malformation. 11. Intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) 12. Participants with active visceral bleeding; 13. Participants with aortic arch dissection; 14. Participants with a known bleeding diathesis or with a platelet count < 100×10^9/L; 15. Participants with a systolic blood pressure = 180 or a diastolic blood pressure = 100 mmHg after repeated measurements and aggressive treatments; 16. Blood glucose <50 or > 400 mg/dl (< 2.8 or > 22.2 mmol / l); 17. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis); 18. Receive intravenous thrombolysis within 24 hours; 19. Receive direct oral anticoagulant therapy with international normalized ratio (INR) > 1.7s or PT > 15 s; 20. Receive low molecular weight heparin or heparinoid within 24 hours; 21. Receive thrombin inhibitors or factor Xa inhibitors within 48 hours; 22. Receive GP2b3a inhibitors within 72 hours; 23. Participants who have large areas (greater than one third of middle cerebral artery territory) of obvious low density on the baseline CT scan; 24. Participants with a seizure at onset thought to be presenting with postictal paralysis (Todd's paralysis) mimicking stroke. 25. Participants with severe infection, such as bacterial endocarditis, pericarditis, acute pancreatitis; 26. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control; 27. Participation in another clinical study with an experimental product in the previous 3 months; 28. Participants deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tiantan Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Tiantan Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days). | Modified Rankin Scale score, mRS 0-1 | at 90-day (± 7 days) | |
| Secondary | Good functional outcome (mRS 0-2) at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | Ordinal distribution of mRS scores at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | NIHSS 0-1 at 24-hour, 7-day or discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased=2 from baseline) | at 24-hour, 7-day or discharge (analyze which occurs first) | ||
| Secondary | Neurological impairment (NIHSS increased=4 from baseline) at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated. | at 90-day (± 7 days) | ||
| Secondary | Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 36-hour, 7-day or discharge (analyze which occurs first). | at 36-hour, 7-day or discharge (analyze which occurs first) | ||
| Secondary | Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | PH2 type intracranial hemorrhage according to the SITS criteria at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | Any intracranial hemorrhage at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | Moderate and severe bleeding events according to the GUSTO criteria at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | Total mortality at 90-day (± 7 days) | at 90-day (± 7 days) | ||
| Secondary | Adverse events/Severe adverse events reported by investigators at 90-day (± 7 days) | at 90-day (± 7 days) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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