Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke

Launched by CAPITAL MEDICAL UNIVERSITY · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called tirofiban to see if it can help prevent worsening neurological symptoms in patients who have had an acute ischemic stroke. An acute ischemic stroke occurs when blood flow to a part of the brain is blocked, and it's often treated with a clot-dissolving drug called thrombolysis. The study will include adults aged 18 and older who have received this treatment within a specific time frame and still show some level of impairment. Participants will need to have a certain level of neurological symptoms at the time they are enrolled in the study.

If someone is eligible and chooses to participate, they will receive either tirofiban or a placebo (a substance with no active medication) within a few hours after starting thrombolysis. Throughout the trial, participants will be closely monitored to assess the safety and effectiveness of the treatment. It's important to note that some individuals may not qualify for the trial due to certain health conditions, such as a recent major surgery or specific types of strokes. This study is not yet recruiting participants, but it aims to gather valuable information that could help improve treatment for future patients with acute ischemic strokes.

Gender

ALL

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. Residual NIHSS score ≥ 5 points at randomization (at least 1 hour after intravenous thrombolytic therapy).
• • 4. Post-thrombolysis imaging shows that the offending artery is consistent with moderate or severe intracranial atherosclerotic stenosis (within 50%\~99%)
• • 5. Informed consent obtained from patients or their acceptable surrogates.
• Exclusion Criteria:
• • 1. Intracranial hemorrhage confirmed by imaging post-thrombolysis.
• • 2. Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.
• • 3. Scheduled for or received endovascular treatment after onset.
• • 4. Definite or suspected cardioembolic stroke.
• • 5. 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).
• • 6. Use of antiplatelet or anticoagulant therapy within one week pre-stroke.
• • 7. Pre-stroke mRS score ≥ 2.
• • 8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) \>1 point at randomization.
• • 9. History of tirofiban allergy or its solvents.
• • 10. History of platelet count \< 100 × 109/L caused by tirofiban.
• • 11. Major surgical operation within 6 weeks.
• • 12. Major systemic hemorrhage within 30 days;
• • 13. Determined coagulation disorders, platelet dysfunction, or platelet count \< 100\*109/L.
• • 14. Currently pregnant or lactating;
• • 15. Uncontrolled hypertension with systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg.
• • 16. Acute pericarditis or hemorrhagic retinopathy.
• • 17. 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).
• • 18. Severe non-cardiovascular complications with an expected survival of less than 6 months.
• • 19. Unavailability for follow-up.
• • 20. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
• • 21. Participated in this study in the past.
• • 22. Current participation in another therapeutic study with ongoing treatment and follow-up.
• • 23. Other conditions that are not suitable for participation in this study as determined by the investigator.