Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling Deficits

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called intravenous thrombolysis, which uses a medication called alteplase, can help patients who have had a mild stroke with specific symptoms. A mild stroke is defined as having a low score on a scale that measures the severity of stroke symptoms. The researchers want to see if giving this treatment within 4.5 hours of the stroke can improve outcomes for patients who experience symptoms like dizziness, disorientation, or weakness in one arm or leg.

To participate in the trial, individuals need to be at least 18 years old and have had a mild stroke or a temporary stroke-like condition within the last 4.5 hours. They should have specific symptoms and a low severity score. However, people with a history of severe strokes, recent head injuries, or certain other medical conditions may not be eligible. Participants can expect to receive either the study treatment or standard care and will be monitored closely for safety and effectiveness. This research aims to provide more clarity on the best treatment options for patients with mild strokes, ultimately helping improve their recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with clinical signs of acute ischemic stroke within 4.5 hours of onset or awakening with stroke (if within 4.5 hours from the midpoint of sleep).
• • 2. Patinet's age is \>18 years
• • 3. Patients with NIHSS ≤ 5, a limb-related NIHSS item score of 0, and with any of the following NIHSS item ≥2: Best Gaze, Visual, Facial palsy, Limb ataxia, Sensory, Best language, Dysarthria, Extinction and Inattention.
• Exclusion Criteria:
• • (1) Plan to receive endovascular treatment; (2) Pre-stroke mRS score \> 2 (3) Contraindications for IVT：
• • 1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)
• • 2. Previous history of intracranial hemorrhage
• • 3. Severe head trauma or stroke history within the last 3 months
• • 4. Intracranial tumors, giant intracranial aneurysms
• • 5. Intracranial or spinal surgery within the recent 3 months
• • 6. Major surgical procedures within the last 2 weeks
• • 7. Gastrointestinal or urinary tract bleeding within the last 3 weeks
• • 8. Active visceral bleeding
• • 9. Aortic arch dissection
• • 10. Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
• • 11. Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
• • 12. Acute bleeding tendency, including platelet count \< 100 × 10⁹/L or other conditions
• • 13. Received low-molecular-weight heparin treatment within 24 hours
• • 14. Oral anticoagulants (warfarin) with INR \> 1.7 or PT \> 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset.
• • 15. Blood sugar \< 2.8 or \> 22.22 mmol/L
• • 16. Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator