A Phase 3 interventional study of Tirofiban+Oral Dual Antiplatelet Therapy and Dual Antiplatelet Therapy plus Normal Saline in Ruptured Intracranial Aneurysms and Subarachnoid Hemorrhage, Aneurysmal, sponsored by First Affiliated Hospital of Fujian Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by First Affiliated Hospital of Fujian Medical University · Phase 3, Interventional, and Treatment
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.
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.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's planned enrollment of 622 is above the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →First Affiliated Hospital of Fujian Medical University is the lead sponsor of 97 studies on the registry; 55 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tirofiban+Oral Dual Antiplatelet Therapy
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.
Drug: Dual Antiplatelet Therapy plus Normal Saline
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.
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.
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
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
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
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
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
Functional outcome assessed by the modified Rankin Scale at 30 days
Distribution of mRS scores and proportion of patients with favorable functional outcomes (mRS 0-2).
Time frame: 30 days after treatment
Functional outcome assessed by the modified Rankin Scale at 180 days
Functional outcomes measured using the mRS at 180 days after treatment.
Time frame: 180 days after treatment
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Plan to share: Undecided
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First Affiliated Hospital of Fujian Medical University