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Completed

NCT Number: NCT06238115

Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Tiantan Hospital

Beijing, China

About this study

Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-80.
  • Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
  • Completion of preoperative antiplatelet preparation.
  • Signed informed consent.

Exclusion criteria

  • Abnormal platelet count (normal reference is 100-300×10^9/L).
  • Allergy to study drugs and anesthetics.
  • Contradictory to MRI examination.
  • Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
  • Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
  • Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
  • Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;
  • Participants with recurrent aneurysms who have received neurointerventional treatment.
  • Inability to follow endovascular procedures due to anatomical difficulties.
  • Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency.
  • Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.
  • Pregnant.

Treatment and study plan

tirofiban

Drug

Initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours.

Aspirin, Clopidogrel

Drug

aspirin 100 mg/day, clopidogrel 75 mg/day

Primary outcomes

  1. The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.

    Time frame: within 48 hours after procedure

  2. The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.

    Time frame: within 48 hours after procedure

Secondary outcomes

  1. Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  2. Incidence of ischemic stroke within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  3. Incidence of transient ischemic attack within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  4. Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  5. Disabling stroke within 30-day after procedure.

    Time frame: at postoperative 30-day

    Disabling stroke is defined as modified Rankin Scale score >1. The modified Rankin Scale score ranges from 0 to 6, and the higher the score, the greater the degree of disability.

Other outcomes

  1. Moderate and severe bleeding events according to the GUSTO criteria within 48-hour after procedure.

    Time frame: at postoperative 48-hour

  2. Moderate and severe bleeding events according to the GUSTO criteria within 30-day after procedure.

    Time frame: at postoperative 30-day

  3. All bleeding events (severe/moderate bleeding and intracranial hemorrhage) within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  4. Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  5. Total mortality within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

  6. Adverse events/Severe adverse events reported by investigators within 48-hour and 30-day after procedure.

    Time frame: at postoperative 48-hour and 30-day

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms

Acronym: TEAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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