Tirofiban After Successful MT Recanalization in AIS

Launched by XIANG LUO · Feb 10, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Tirofiban After Successful MT Recanalization in AIS," is studying the effectiveness and safety of a medication called tirofiban for patients who have experienced an acute ischemic stroke due to a blockage in a major blood vessel. The trial is designed for adults aged 18 and older who have had a stroke within the last 24 hours, have certain symptoms, and have undergone a procedure to remove the blockage successfully. Tirofiban may help prevent the blood vessels from becoming blocked again and improve blood flow to the brain, which could lead to better recovery outcomes.

Participants in the trial will be randomly assigned to receive either tirofiban or a placebo (a substance with no active medical effect) after their blockage has been treated. Throughout the study, participants will be closely monitored for any side effects and to see how well they recover. This research is important as it aims to improve treatment options for stroke patients and provide better long-term outcomes. If you meet the eligibility criteria and are interested in participating, your healthcare team can provide more information about the study and answer any questions you may have.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old;
• • 2. NIHSS score: 6-30;
• • 3. Symptom onset to random time of 24h, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.
• • 4. mRS 0-1 before the stroke;
• • 5. Subject or legal representative can sign an informed consent form;
• • 6. Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery;
• • 7. ASPECTS≥6 on NCCT or DWI;
• • 8. After the end of mechanical thrombectomy, the mTICI was stable at 2b/3, and there was no secondary embolism in other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned.
• Exclusion Criteria:
• • 1. Intra-arterial thrombolysis;
• • 2. Tirofiban was used within 24 hours before endovascular treatment
• • 3. Women who are known to be pregnant or lactating, or have a positive pregnancy test before randomization;
• • 4. Allergy to tirofiban, radiocontrast agent or Nitinol materials;
• • 5. Any active bleeding within 30 days before stroke or recent bleeding (gastrointestinal, urinary, etc.);
• • 6. parenchymal organ surgery or biopsy within 14 days before stroke;
• • 7. History of heparin-induced thrombocytopenia;
• • 8. Platelet count \< 100\*10\^9/L;
• • 9. Being on hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate \&lt; 30ml/min or serum creatinine \&gt; 220μmol/L).
• • 10. Subjects requiring hemodialysis or peritoneal dialysis or who have contraindications to angiography for any reason;
• • 11. The expected survival time is less than half a year (such as malignant tumors, serious heart and lung diseases, etc.);
• • 12. Have participated in other interventional clinical studies that may have an impact on the outcome assessment;
• • 13. Other circumstances that the investigator considers inappropriate for participation in the study or that may pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorder).
• • 14. The midline shift of the brain or cerebral hernia, ventricular mass effect;
• • 15. Acute intracranial hemorrhage on CT or MRI;
• • 16. New bilateral acute stroke or intracranial multi-drainage large vessel occlusion;
• • 17. Simple extracranial occlusion of the internal carotid artery.