Low Dose Prasugrel vs Clopidogrel for Stenting or Flow Diverter for Unruptured Aneurysm

  • STATUS
    Recruiting
  • End date
    Aug 23, 2025
  • participants needed
    406
  • sponsor
    Yonsei University
Updated on 4 October 2022
aspirin
embolization procedure
Accepts healthy volunteers

Summary

Low clopidogrel response has been reported in about 5-44% of the total population, which is associated with an increase in thromboembolism.

Recently prasugrel drug widely accepted as a good option for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.

Description

Unruptured intracranial aneurysm (UIA) is a relatively common disease with a prevalence of about 1% of the total population. Widely accepted techniques of neuro-interventional therapy are coil embolization with or without stent deployment and flow diverter insertion. However, these two techniques inevitably had the risk of thromboembolism. For prevention and decrease, dual antiplatelet therapy is commonly used in the clinical field. However, clopidogrel does not produce normal metabolites due to various internal and external factors in the metabolic process in the liver and eventually fails to perform its original role of platelet activity suppression in many situations, called "clopidogrel hyporesponsive". Low clopidogrel response has been reported in about 5-44% of the total population, which is associated with an increase in thromboembolism.

Recently prasugrel drug widely accepted as a good option for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.

Details
Condition Intracranial Aneurysm
Treatment Prasugrel group, Clopidogrel group
Clinical Study IdentifierNCT05359224
SponsorYonsei University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

UIAs without any evidence of rupture in intracranial imaging study within the last 6 months
Planned treatment with coil embolization with stent insertion or flow diverter insertion
If the patient himself/herself consented to this study

Exclusion Criteria

∙ History of acute ischemic stroke or transient ischemic attack
Any intracranial hemorrhage except subarachnoid hemorrhage due to aneurysm rupture within the last 3 months
Concurrent treatment other than endovascular procedure (e.g. open craniotomy and microsurgical clipping)
Contraindications to iodine contrast agents
Already taking antiplatelet drugs or antithrombotic drugs other than aspirin
Hypersensitivity to aspirin, prasugrel or clopidogrel
Cardiac arrhythmia that should be needed to take anticoagulants
Pregnancy or lactating
Chronic kidney disease (< GFR 60)
Patients with chronic liver disease who have at least over 100 IU/L of either AST/ALT in the liver function test
Patients with pathological active bleeding, such as peptic ulcer
Patients with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption because they contain lactose
Patients continuously taking non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 inhibitors
Patients requiring concomitant administration of methotrexate 15 mg or more for one week
If it is judged difficult to follow up after treatment
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