Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

Phase 2

Recruiting

• Conditions: Unruptured Intracranial Aneurysm; Stent-assisted Coiling; Flow Diverter; Thromboembolic Events
• Interventions: Drug: aspirin, clopidogrel; Drug: Tirofiban

• Registration Number: NCT06238115
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.

Detailed Description

This is a single-center, open-label, assessor-blinded randomized controlled trial. Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-02
• Status Verified: 2024-03
• Study Start: 2024-03-04
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard medical care	aspirin, clopidogrel	Routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day)
Tirofiban group	aspirin, clopidogrel	After femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours.
Tirofiban group	Tirofiban	After femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours.

Primary Outcome Measures

Name	Time	Method
The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.	within 48 hours after procedure
The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.	within 48 hours after procedure

Secondary Outcome Measures

Name	Time	Method
Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.	at postoperative 48-hour and 30-day
Incidence of ischemic stroke within 48-hour and 30-day after procedure.	at postoperative 48-hour and 30-day
Incidence of transient ischemic attack within 48-hour and 30-day after procedure.	at postoperative 48-hour and 30-day
Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.	at postoperative 48-hour and 30-day
Disabling stroke within 30-day after procedure.	at postoperative 30-day	Disabling stroke is defined as modified Rankin Scale score \>1. The modified Rankin Scale score ranges from 0 to 6, and the higher the score, the greater the degree of disability.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China