CompletedPhase 2/3

Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

China192 participantsStarted 2024-03-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

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

Timeframe: within 48 hours after procedure

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

Timeframe: within 48 hours after procedure

Trial details

NCT IDNCT06238115

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-09

View on ClinicalTrials.gov More Unruptured Intracranial Aneurysm trials