Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

NCT ID: NCT06238115

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-11-09

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study 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.

Group Type: EXPERIMENTAL

Tirofiban

Intervention Type: DRUG

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.

aspirin, clopidogrel

Intervention Type: DRUG

aspirin 100 mg/day, clopidogrel 75 mg/day

Standard medical care

Routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day)

Group Type: PLACEBO_COMPARATOR

aspirin, clopidogrel

Intervention Type: DRUG

aspirin 100 mg/day, clopidogrel 75 mg/day

Interventions

Tirofiban

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.

Intervention Type: DRUG

aspirin, clopidogrel

aspirin 100 mg/day, clopidogrel 75 mg/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ages 18-80.

2. Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.

3. Completion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Jing

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

Other Identifiers

CSA2022KY009

Identifier Type: -

Identifier Source: org_study_id