Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

NCT06238115 | Completed Phase 2

• 1 other identifier: CSA2022KY009
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unruptured Intracranial Aneurysm; Flow Diverter; Stent-assisted Coiling; Thromboembolic Events

Outcome Measures

Primary Outcomes (2)

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

  within 48 hours after procedure

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

  within 48 hours after procedure

Secondary Outcomes (5)

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

  at postoperative 48-hour and 30-day

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

  at postoperative 48-hour and 30-day

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

  at postoperative 48-hour and 30-day

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

  at postoperative 48-hour and 30-day

• Disabling stroke within 30-day after procedure.

  at postoperative 30-day

Other Outcomes (6)

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

  at postoperative 48-hour

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

  at postoperative 30-day

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

  at postoperative 48-hour and 30-day

Study Arms (2)

Tirofiban group

EXPERIMENTAL

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.

Drug: Tirofiban; Drug: aspirin, clopidogrel

Standard medical care

PLACEBO COMPARATOR

Routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day)

Drug: aspirin, clopidogrel

Interventions

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.

Tirofiban group

aspirin, clopidogrel DRUG

aspirin 100 mg/day, clopidogrel 75 mg/day

Standard medical care; Tirofiban group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Thromboembolism

Interventions

Tirofiban; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jing Jing

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 2, 2024
• Study Start: March 4, 2024
• Primary Completion: October 9, 2025
• Study Completion: November 9, 2025
• Last Updated: December 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)