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

Fujian Medical University (FJMU)

Status and phase: Not yet enrolling; Phase 3

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Ruptured Intracranial Aneurysms

Treatments: Drug: Tirofiban+Oral Dual Antiplatelet Therapy; Drug: Dual Antiplatelet Therapy plus Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07818083

2023ZD0505102 (Other Grant/Funding Number)

MRCTA,ECFAH of FMU[2026]657

Details and patient eligibility

About

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.

Full description

Ruptured intracranial aneurysm accompanied by subarachnoid hemorrhage carries high risks of disability and mortality. Stent-assisted coiling has become a mainstream emergency interventional therapy for this condition. Conventional dual antiplatelet therapy with aspirin and clopidogrel is routinely applied perioperatively, yet clopidogrel resistance is common among Asian populations, which greatly elevates the risk of delayed cerebral infarction and poor long-term neurological recovery. Tirofiban is a rapid-onset, reversible intravenous antiplatelet agent that can effectively suppress platelet aggregation, but high-level evidence from large multicenter randomized controlled trials is still lacking to standardize its administration strategy in emergency stent-assisted embolization for ruptured intracranial aneurysms. To fill this gap in clinical evidence and optimize perioperative antithrombotic regimens, this multicenter prospective randomized controlled trial is designed to compare tirofiban-enhanced antiplatelet therapy against traditional dual antiplatelet treatment. Eligible subjects will be recruited from multiple tertiary hospitals across China. After successful stent implantation during endovascular surgery, participants will be randomly assigned to two groups in a 1:1 ratio. The experimental group will receive perioperative tirofiban combined with standard preoperative oral dual antiplatelet therapy, while the control group will be given matched volume perioperative saline plus standard oral dual antiplatelet therapy. Patients and evaluators responsible for imaging interpretation and neurological function scoring will remain blinded to group allocation to reduce assessment bias. Multiple scheduled follow-up visits will be arranged to record imaging findings, hemorrhagic and thromboembolic adverse events, and neurological function scores at preset time points. The primary endpoint focuses on patients' neurological functional prognosis 90 days after intervention, while secondary outcomes include short-term cerebral infarction incidence, aneurysm occlusion status, long-term functional recovery and all-cause mortality. Major safety indicators will monitor moderate to severe bleeding events within the early postoperative phase. This trial has obtained formal ethical approval, and standardized data management, monitoring and quality control procedures will be implemented throughout the whole research process to guarantee data authenticity and trial compliance with clinical research specifications. This is a clinical trial with a total research period of nearly three years, including the enrollment phase and long-term follow-up for each enrolled subject.

Enrollment: 622 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

622 participants in 2 patient groups, including a placebo group

Enhanced Antiplatelet Group

Experimental group

Description:

All subjects receive oral aspirin 300mg plus clopidogrel 300mg 2 hours before operation. After stent deployment, tirofiban 5μg/kg is intravenously bolus injected within 20 seconds, followed by continuous intravenous infusion at 0.075μg/(kg·min) for 24 hours. Long-term oral aspirin 100mg and clopidogrel 75mg daily are administered for 90 days after bridging antiplatelet therapy.

Treatment:

Drug: Tirofiban+Oral Dual Antiplatelet Therapy

Conventional Antiplatelet Group

Placebo Comparator group

Description:

All subjects receive oral aspirin 300mg plus clopidogrel 300mg 2 hours before operation. After stent deployment, equal volume normal saline is intravenously bolus injected and continuously pumped for 24 hours with the same duration. Long-term oral aspirin 100mg and clopidogrel 75mg daily are maintained for 90 days.

Treatment:

Drug: Dual Antiplatelet Therapy plus Normal Saline