Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

Launched by BEIJING TIANTAN HOSPITAL · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tirofiban to see if it can help reduce the risk of new blood clots in patients undergoing procedures for unruptured brain aneurysms. Specifically, researchers want to find out if tirofiban is more effective than the standard treatment, which involves using two types of blood-thinning medications, during stent-assisted coiling or flow diversion treatments. These procedures help to prevent aneurysms from growing or bursting.

To be eligible for the trial, participants should be between the ages of 18 and 80 and have unruptured brain aneurysms that can be treated with these specific methods. They must also have completed any required blood-thinning preparation before surgery and provide their consent to join the study. If someone is considering joining, they can expect to undergo regular check-ups and imaging tests after their procedure to monitor their recovery and assess any new blood clots. It's important to know that certain health conditions or medications might prevent someone from participating, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 18-80.
• • 2. Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
• • 3. Completement of preoperative antiplatelet preparation.
• • 4. Signed informed consent.
• Exclusion Criteria:
• • 1. Abnormal platelet count (normal reference is 100-300×10\^9/L).
• • 2. Allergy to study drugs and anesthetics.
• • 3. Contradictory to MRI examination.
• • 4. Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
• • 5. Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
• • 6. Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
• • 7. Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;
• • 8. Participants with recurrent aneurysms who have received neurointerventional treatment.
• • 9. Inability to follow endovascular procedures due to anatomical difficulties.
• • 10. Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST \> twice the upper limit of normal range) insufficiency.
• • 11. Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.
• • 12. Pregnant.