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

Intracranial Aneurysm Clinical Trial

Official title:

Low-dose Prasgurel Versus Clopidogrel on the Dual Antiplatelet Regimen for Intracranial Stenting or Flow Diverter Treatment for Unruptured Cerebral Aneurysms: a Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359224
• Other study ID #: S6700
• Status: Recruiting
• Phase: Phase 4
• Start date: June 13, 2022
• Est. completion date: August 2025

Study information

• Verified date: July 2022
• Source: Yonsei University
• Contact: Chang Ki Jang
• Phone: 82-031-5189-8484
• Email: changgeejang[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Drug:
• Prasugrel group
Prescribe the drugs according to the assigned group, and take them 5 days before the procedure. Perform platelet function test (VerifyNow assay; Accumetrics, San Diego, California) one day before the procedure to check the P2Y12 reaction reactivity. And the hyporesponsive group patient is given prasugrel 5mg once. And aspirin 100mg and prasugrel 5mg will be maintained for 30 days.
• Clopidogrel group
Prescribe the drugs according to the assigned group, and take them 5 days before the procedure. Perform platelet function test (VerifyNow assay; Accumetrics, San Diego, California) one day before the procedure to check the P2Y12 reaction reactivity. And the hyporesponsive group patient is given pletaal 100mg once. And aspirin 100mg and clopidogrel 75mg mg will be maintained for 30 days.

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance hospital, Yonsei university college of medicine	Gyeonggi-do	Yongin-si

Sponsors (6)

Lead Sponsor	Collaborator
Yonsei University	Bucheon St. Mary's Hospital, Ewha Woman's University Seoul Hospital, Gangnam Severance Hospital, International St. Mary's Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri-procedural thromboembolic complications	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.	30 days
Secondary	thromboembolic safety endpoint	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.	30days
Secondary	bleeding safety endpoint	major and minor bleeding within 30days after procedure; :: incidence of treatment-major and minor bleeding	30days