About this trial
This multicenter prospective randomized controlled study will enroll patients with ruptured intracranial aneurysms receiving stent-assisted coiling across multiple Chinese medical centers. The investigators aim to evaluate the efficacy and safety of tirofiban-enhanced antiplatelet therapy versus conventional dual antiplatelet treatment on the 90-day neurological prognosis and major adverse cerebrovascular events of enrolled subjects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years; Acute subarachnoid hemorrhage confirmed by head CT, with a WFNS grade of 1-4; DSA-confirmed aneurysmal SAH treated with successful stent deployment; Surgical intervention performed within 72 hours after symptom onset.
Disqualifiers
Blood blister-like aneurysms or recurrent aneurysms; Abnormal coagulation profiles (INR >1.5 or platelet count <100 × 10⁹/L); Pregnancy, peripartum status, or lactation; Secondary aneurysm rupture due to infection, trauma, tumor invasion, vascular malformation, moyamoya disease, or other pathological causes; Concomitant intracranial hemorrhage; Hypersensitivity to amikacin, ceftriaxone, or related drugs; Autoimmune diseases (e.g., systemic lupus erythematosus); Severe comorbidities, life expectancy ≤3 months, or other investigator-determined reasons precluding enrollment.
Trial design
Parallel
Treatments tested in this trial
Tirofiban+Oral Dual Antiplatelet Therapy
DrugPreoperative oral loading dose: Aspirin 300 mg and Clopidogrel 300 mg. After stent deployment, tirofiban 5 μg/kg intravenous bolus, then continuous infusion at 0.075 μg/(kg・min) for 24 hours. Postoperative maintenance: oral Aspirin 100 mg and Clopidogrel 75 mg once daily for 90 days.
Dual Antiplatelet Therapy plus Normal Saline
DrugAspirin 300 mg and Clopidogrel 300 mg. After stent deployment, equal volume normal saline is given via intravenous bolus and continuous infusion for 24 hours. Postoperative maintenance: oral Aspirin 100 mg and Clopidogrel 75 mg once daily for 90 days.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days After Endovascular Treatment
Secondary outcomes
Incidence of new cerebral infarction within 7 days after treatment
The occurrence of new ischemic lesions detected by postoperative CT within 7 days after treatment, with lesion diameter ≥1 cm.
Incidence of extracranial thromboembolic events within 7 days after treatment
The incidence of thromboembolic events other than intracranial thrombosis occurring within 7 days after treatment.
Rate of complete aneurysm occlusion after endovascular treatment
Complete aneurysm occlusion assessed according to the Raymond-Roy occlusion classification after stent-assisted coiling.
Aneurysm recurrence rate at 3 months after treatment
The proportion of patients with aneurysm recurrence detected during follow-up.
Locations
Sponsors and contacts
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