Clinical trial NCT06238115: Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair
Official title: Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Unruptured Intracranial Aneurysm
Flow Diverter
Stent-assisted Coiling
Thromboembolic Events
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
timeFrame: within 48 hours after procedure
measure: The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
timeFrame: within 48 hours after procedure
Secondary outcomes:
measure: Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Incidence of ischemic stroke within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Incidence of transient ischemic attack within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Disabling stroke within 30-day after procedure.
timeFrame: at postoperative 30-day
Other outcomes:
measure: Moderate and severe bleeding events according to the GUSTO criteria within 48-hour after procedure.
timeFrame: at postoperative 48-hour
measure: Moderate and severe bleeding events according to the GUSTO criteria within 30-day after procedure.
timeFrame: at postoperative 30-day
measure: All bleeding events (severe/moderate bleeding and intracranial hemorrhage) within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Total mortality within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
measure: Adverse events/Severe adverse events reported by investigators within 48-hour and 30-day after procedure.
timeFrame: at postoperative 48-hour and 30-day
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jing Jing
role: STUDY_CHAIR
References: