Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair (TEAR)

Capital Medical University

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Tirofiban; Drug: aspirin, clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT06238115

CSA2022KY009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups, including a placebo group

Tirofiban group

Experimental group

Description:

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.

Treatment:

Drug: aspirin, clopidogrel

Drug: Tirofiban

Standard medical care

Placebo Comparator group

Description:

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

Treatment:

Drug: aspirin, clopidogrel