The Efficacy and Safety of Tirofiban Enhanced Antiplatelet Therapy in the Treatment of Ruptured Intracranial Aneurysms With Stent

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Fujian Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tirofiban+Oral Dual Antiplatelet Therapy

    Drug

    Preoperative 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

    Drug

    Aspirin 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

622 Participants
are divided into 2 treatment groups
Group A: Enhanced Antiplatelet GroupExperimental treatment 1 intervention
Group B: Conventional Antiplatelet GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days After Endovascular Treatment

Time frame
90 days after stent-assisted embolization

Secondary outcomes

1

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.

Time frame
Within 7 days after treatment
2

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.

Time frame
Within 7 days after treatment
3

Rate of complete aneurysm occlusion after endovascular treatment

Complete aneurysm occlusion assessed according to the Raymond-Roy occlusion classification after stent-assisted coiling.

Time frame
Immediately after procedure
4

Aneurysm recurrence rate at 3 months after treatment

The proportion of patients with aneurysm recurrence detected during follow-up.

Time frame
3 months after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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