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

Phase 4

Recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Drug: Clopidogrel group; Drug: Prasugrel group

• Registration Number: NCT05359224
• Lead Sponsor: Yonsei University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Study Start: 2022-06-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 406

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel group	Using a randomization program, the test group (203 patients; Aspirin 100 mg + Prasugrel 5 mg) and control group (203 patients; Aspirin 100 mg + Clopidogrel 75 mg) are classified. Prescribe the above drugs according to the assigned group, and take them 5 days before the procedure.
prasugrel	Prasugrel group	Using a randomization program, the test group (203 patients; Aspirin 100 mg + Prasugrel 5 mg) and control group (203 patients; Aspirin 100 mg + Clopidogrel 75 mg) are classified. Prescribe the above drugs according to the assigned group, and take them 5 days before the procedure.

Primary Outcome Measures

Name	Time	Method
peri-procedural thromboembolic complications	30 days	* thromboembolism detected during the neurointerventional procedure; * transient ischemic attack or ischemic stroke or death with evidence of infarction on diffusion weighted imaging, which occurs within 30-days after procedure; * incidence of treatment-thromboembolic, TIA and death events.

Secondary Outcome Measures

Name	Time	Method
thromboembolic safety endpoint	30days	* Ischemic stroke on relevant arterial territory within 30days after procedure or any stroke; * Diffusion restriction lesion detected on post-procedure 7 days MRI; * incidence of treatment-ischemic stroke on relevant territory and DWI lesion detected.
bleeding safety endpoint	30days	major and minor bleeding within 30days after procedure; :: incidence of treatment-major and minor bleeding

Trial Locations

Locations (1)

Yongin Severance hospital, Yonsei university college of medicine; 🇰🇷 Gyeonggi-do, Yongin-si, Korea, Republic of