Using tirofiban to reduce blood clots during aneurysm repair procedures

Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms

This study is testing if the medication tirofiban can help reduce blood clots in patients undergoing procedures for unruptured brain aneurysms.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06238115 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of tirofiban, a medication, in reducing ischemic lesions in patients undergoing stent-assisted coiling or flow diversion for unruptured intracranial aneurysms. Participants will be randomly assigned to receive either tirofiban or a placebo alongside standard dual antiplatelet therapy. The primary outcome will be measured through diffusion weighted imaging (DWI) to assess the number and volume of ischemic lesions within 48 hours post-procedure. The study aims to determine if tirofiban can provide a significant advantage over conventional treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion.

Not a fit: Patients with abnormal platelet counts, allergies to study drugs, or a history of significant bleeding events may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to fewer thromboembolic events and improved outcomes for patients undergoing aneurysm repair.

How similar studies have performed: While the use of tirofiban in this specific context is novel, similar studies have shown promise in reducing thromboembolic events in other vascular interventions.

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Qianmei Jiang

Conditions Unruptured Intracranial Aneurysm; Flow Diverter; Stent-assisted Coiling; Thromboembolic Events