Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time … (NCT07476898) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window
China864 participantsStarted 2026-03-01
Plain-language summary
To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects (age ≥ 18 years).
* Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.
* Time from stroke onset or last known well to randomization is 4.5 to 24 hours.
* NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.
* LVO (internal carotid artery, middle cerebral artery M1/M2 segments) confirmed by CTA or MRA, including tandem lesions.
* Core infarct volume \< 70 ml, ischemic penumbra volume ≥ 15 ml, and mismatch ratio ≥ 1.8, as shown by CTP or MRI+MRP.
* Written informed consent.
Exclusion Criteria:
* Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).
* History of stroke within the last 3 months.
* History of intracranial hemorrhage.
* Suspected subarachnoid hemorrhage.
* Intracranial tumor, vascular malformation, or aneurysm.
* Major surgery within the last 1 month.
* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
* Platelet count \< 10⁵/mm³.
* Heparin or oral anticoagulant therapy within 48 hours.
…
What they're measuring
1
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.