Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Launched by CAPITAL MEDICAL UNIVERSITY · Aug 8, 2024

Keywords

ClinConnect Summary

The TREND-IVT clinical trial is studying whether giving aspirin to patients right after they receive a treatment called intravenous thrombolysis (which helps break up blood clots during a stroke) can improve their recovery without increasing the risk of bleeding in the brain. This trial is important because while thrombolysis is effective, some patients may still experience worsening symptoms due to increased platelet activity. Currently, guidelines suggest starting aspirin 24 hours after thrombolysis, but this study aims to find out if starting it sooner could lead to better outcomes.

To participate in this trial, you need to be at least 18 years old and have had an acute ischemic stroke treated with thrombolysis within 4.5 hours of symptom onset. You should also have a specific level of improvement or worsening in your symptoms shortly after treatment. However, there are several reasons why someone might not be eligible, such as having certain types of strokes or medical conditions that could complicate treatment. If you qualify and choose to join, you will receive close monitoring and support throughout the study to help ensure your safety and health.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old;
• • 2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
• • 3. NIHSS score improvement ≤ 2 points or worsening ≤ 4 points one hour after initiating intravenous thrombolysis compared to pre-thrombolysis.
• • 4. Residual NIHSS score \> 5 points at randomization.
• • 5. Informed consent obtained from patients or their acceptable surrogates.
• Exclusion Criteria:
• • 1. Stroke caused by definite large vessel occlusion (including A1 and A2 segments of the anterior cerebral artery, M1 and M2 segments of the middle cerebral artery, P1 and P2 segments of the posterior cerebral artery, intracranial and extracranial segments of the internal carotid artery, basilar artery, and bilateral vertebral artery occlusion) confirmed by imaging (including CTA or MRA).
• • 2. Scheduled for endovascular treatment.
• • 3. Intracranial hemorrhage confirmed by imaging post-thrombolysis.
• • 4. Definite or suspected cardioembolic stroke.
• • 5. Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.
• • 6. Pre-stroke mRS score \> 1.
• • 7. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points.
• • 8. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area.
• • 9. Prior history of stroke events (manifesting as stroke symptoms, including hemorrhagic stroke and ischemic stroke).
• • 10. Known contraindications for antiplatelet therapy, such as coagulation disorders, systemic bleeding, etc.
• • 11. History of aspirin allergy.
• • 12. Use of antiplatelet or anticoagulant therapy within one week pre-stroke.
• • 13. There is definite anticipation of developing indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state).
• • 14. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \< 30 ml/min or serum Cr \> 220 μmol/L (2.5 mg/dl)), severe hepatic insufficiency (serum ALT \> 2 times the upper limit of normal, or serum AST \> 2 times the upper limit of normal), severe heart failure (NYHA class III or IV).
• • 15. Severe non-cardiovascular complications with an expected survival of less than 6 months.
• • 16. Unavailability for follow-up.
• • 17. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
• • 18. Current participation in another therapeutic study with ongoing treatment and follow-up.
• • 19. Other conditions that are not suitable for participation in this study as determined by the investigator.