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Ruptured Intracranial AneurysmsPhase 3TEARIASNCT07818083

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

A Phase 3 study testing Tirofiban+Oral Dual Antiplatelet Therapy and Dual Antiplatelet Therapy plus Normal Saline in people with Ruptured Intracranial Aneurysms and Subarachnoid Hemorrhage, Aneurysmal, run by First Affiliated Hospital of Fujian Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicenter prospective randomized controlled study will enroll patients with ruptured intracranial aneurysms receiving stent-assisted coiling across multiple Chinese medical centers. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tirofiban+Oral Dual Antiplatelet Therapy and Dual Antiplatelet Therapy plus Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
622 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fuxin Lin, MD contact

+86 13600893154

lfxstudy@126.com

About this study

Official title: The Efficacy and Safety of Tirofiban Enhanced Antiplatelet Therapy in the Treatment of Ruptured Intracranial Aneurysms With Stent (TEARIAS): A Multicenter, Open-Label, Single-Blind, Randomized Controlled 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.

Read the detailed 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.

Being tested
Tirofiban+Oral Dual Antiplatelet Therapy, Dual Antiplatelet Therapy plus Normal Saline
Keywords
Subarachnoid Hemorrhage, Ruptured Intracranial Aneurysms, Tirofiban, Dual Antiplatelet Therapy
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tirofiban+Oral Dual Antiplatelet TherapyDrug

    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 SalineDrug

    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.

Study groups in NCT07818083
Study groupRoleWhat they receive
Enhanced Antiplatelet GroupExperimentalAll 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.
Receives: Drug: Tirofiban+Oral Dual Antiplatelet Therapy
Conventional Antiplatelet GroupPlacebo comparatorAll 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.
Receives: Drug: Dual Antiplatelet Therapy plus Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 90 days after stent-assisted embolization

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: Immediately after procedure

  4. Aneurysm recurrence rate at 3 months after treatment

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

    Measured: 3 months after treatment

  5. 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).

    Measured: 30 days after treatment

  6. Functional outcome assessed by the modified Rankin Scale at 180 days

    Functional outcomes measured using the mRS at 180 days after treatment.

    Measured: 180 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
622 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07818083
Sponsor's protocol ID
MRCTA,ECFAH of FMU[2026]657
Other IDs
2023ZD0505102
Acronym
TEARIAS
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liang XD, Wang ZL, Li TX, He YK, Bai WX, Wang YY, Zhou GY. Safety and efficacy of a new prophylactic tirofiban protocol without oral intraoperative antiplatelet therapy for endovascular treatment of ruptured intracranial aneurysms. J Neurointerv Surg. 2016 Nov;8(11):1148-1153. doi: 10.1136/neurintsurg-2015-012055. Epub 2015 Nov 27.

    PubMed 26614492
  • Reddy D, Fallah A, Petropoulos JA, Farrokhyar F, Macdonald RL, Jichici D. Prophylactic magnesium sulfate for aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. Neurocrit Care. 2014 Oct;21(2):356-64. doi: 10.1007/s12028-014-9964-0.

    PubMed 24619389
  • Jeon JS, Sheen SH, Hwang G, Kang SH, Heo DH, Cho YJ. Intravenous magnesium infusion for the prevention of symptomatic cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Korean Neurosurg Soc. 2012 Aug;52(2):75-9. doi: 10.3340/jkns.2012.52.2.75. Epub 2012 Aug 31.

    PubMed 23091662
  • Vergouwen MD, de Haan RJ, Vermeulen M, Roos YB. Effect of statin treatment on vasospasm, delayed cerebral ischemia, and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis update. Stroke. 2010 Jan;41(1):e47-52. doi: 10.1161/STROKEAHA.109.556332. Epub 2009 Oct 29.

    PubMed 19875741
  • Shen J, Huang KY, Zhu Y, Pan JW, Jiang H, Weng YX, Zhan RY. Effect of statin treatment on vasospasm-related morbidity and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Neurosurg. 2017 Aug;127(2):291-301. doi: 10.3171/2016.5.JNS152900. Epub 2016 Oct 7.

    PubMed 27715439
  • Togashi K, Joffe AM, Sekhar L, Kim L, Lam A, Yanez D, Broeckel-Elrod JA, Moore A, Deem S, Khandelwal N, Souter MJ, Treggiari MM. Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (IMPROVES). Neurosurgery. 2015 Feb;76(2):125-34; discussion 134-5; quiz 135. doi: 10.1227/NEU.0000000000000592.

    PubMed 25549192
  • Loan JJM, Wiggins AN, Brennan PM. Medically induced hypertension, hypervolaemia and haemodilution for the treatment and prophylaxis of vasospasm following aneurysmal subarachnoid haemorrhage: systematic review. Br J Neurosurg. 2018 Apr;32(2):157-164. doi: 10.1080/02688697.2018.1426720. Epub 2018 Jan 17.

    PubMed 29338431
  • Choudhari K. Prophylactic hyperdynamic postoperative fluid therapy after aneurysmal subarachnoid hemorrhage: a clinical, prospective, randomized, controlled study. Neurosurgery. 2002 May;50(5):1170-1; author reply 1171-2. doi: 10.1097/00006123-200205000-00057. No abstract available.

    PubMed 11987280
  • Lennihan L, Mayer SA, Fink ME, Beckford A, Paik MC, Zhang H, Wu YC, Klebanoff LM, Raps EC, Solomon RA. Effect of hypervolemic therapy on cerebral blood flow after subarachnoid hemorrhage : a randomized controlled trial. Stroke. 2000 Feb;31(2):383-91. doi: 10.1161/01.str.31.2.383.

    PubMed 10657410
  • Tejada JG, Taylor RA, Ugurel MS, Hayakawa M, Lee SK, Chaloupka JC. Safety and feasibility of intra-arterial nicardipine for the treatment of subarachnoid hemorrhage-associated vasospasm: initial clinical experience with high-dose infusions. AJNR Am J Neuroradiol. 2007 May;28(5):844-8.

    PubMed 17494654
  • Stuart RM, Helbok R, Kurtz P, Schmidt M, Fernandez L, Lee K, Badjatia N, Mayer SA, Lavine S, Meyers P, Connolly ES, Claassen J. High-dose intra-arterial verapamil for the treatment of cerebral vasospasm after subarachnoid hemorrhage: prolonged effects on hemodynamic parameters and brain metabolism. Neurosurgery. 2011 Feb;68(2):337-45; discussion 345. doi: 10.1227/NEU.0b013e318201be47.

    PubMed 21135735
  • Shankar JJ, dos Santos MP, Deus-Silva L, Lum C. Angiographic evaluation of the effect of intra-arterial milrinone therapy in patients with vasospasm from aneurysmal subarachnoid hemorrhage. Neuroradiology. 2011 Feb;53(2):123-8. doi: 10.1007/s00234-010-0720-7. Epub 2010 Jun 5.

    PubMed 20549498
  • Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35.

    PubMed 19057319
  • Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.

    PubMed 18239182
  • Feng L, Fitzsimmons BF, Young WL, Berman MF, Lin E, Aagaard BD, Duong H, Pile-Spellman J. Intraarterially administered verapamil as adjunct therapy for cerebral vasospasm: safety and 2-year experience. AJNR Am J Neuroradiol. 2002 Sep;23(8):1284-90.

    PubMed 12223366

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirofiban+Oral Dual Antiplatelet Therapy and Dual Antiplatelet Therapy plus Normal Saline in people with Ruptured Intracranial Aneurysms and Subarachnoid Hemorrhage, Aneurysmal, run by First Affiliated Hospital of Fujian Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fuxin Lin, MD (+86 13600893154, lfxstudy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07818083, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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