Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window

Starting soon · Phase 3

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT07476898

Run by

First Hospital of China Medical University

People needed

864

Starts

2026-03-01

Expected to finish

2028-08-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Abnormal APTT.
• Thrombin or factor Xa inhibitors.
• Severe illness with life expectancy < 3 months.
• Blood glucose < 50 mg/dL (2.7 mmol/L).
• Participation in any other investigational drug or device study within the last 3 months.
• Pregnancy.
• Patients deemed unsuitable for the registry study by the investigator.

Where it is running

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• Anshan Central Hospital — Anshan, Liaoning, China
• Anshan Changda Hospital — Anshan, Liaoning, China
• Benxi Central Hospital — Benxi, Liaoning, China
• Chaoyang Central Hospital — Chaoyang, Liaoning, China
• Dalian Municipal Central Hospital Affiliated of Dalian University of Technology — Dalian, Liaoning, China
• Dandong Central Hospital — Dandong, Liaoning, China
• Dandong First Hospital — Dandong, Liaoning, China
• Fushun Central Hospital — Fushun, Liaoning, China
• Liaojian Group Fukuang General Hospital — Fushun, Liaoning, China
• Fuxin People's Hospital — Fuxin, Liaoning, China
• Huludao Central Hospital — Huludao, Liaoning, China
• The First Affiliated Hospital of Jinzhou Medical University — Jinzhou, Liaoning, China
• Liaoyang Central Hospital — Liaoyang, Liaoning, China
• Panjin Central Hospital — Panjin, Liaoning, China
• The Second Affiliated Hospital of Shenyang Medical College — Shenyang, Liaoning, China
• Liaoning Provincial People's Hospital — Shenyang, Liaoning, China
• Shenyang Fifth People's Hospital — Shenyang, Liaoning, China
• Central Hospital Affiliated to Shenyang Medical College — Shenyang, Liaoning, China
• Shenyang Fourth People's Hospital — Shenyang, Liaoning, China
• The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China
• Shenyang First People's Hospital — Shenyang, Liaoning, China
• Shenyang Tenth People's Hospital — Shenyang, Liaoning, China
• Sujiatun District Central Hospital — Shenyang, Liaoning, China
• Tieling Central Hospital — Tieling, Liaoning, China

Full record on ClinicalTrials.gov

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