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

NCT ID: NCT05359224

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2025-08-31

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel

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.

Group Type: ACTIVE_COMPARATOR

Clopidogrel group

Intervention Type: DRUG

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.

prasugrel

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.

Group Type: ACTIVE_COMPARATOR

Prasugrel group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

effient; plavix

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role: collaborator

Bucheon St. Mary's Hospital

OTHER

Sponsor Role: collaborator

International St. Mary's Hospital

UNKNOWN

Sponsor Role: collaborator

Ewha Woman's University Seoul Hospital

UNKNOWN

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Chang Ki Jang

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang Ki Jang

Role: STUDY_DIRECTOR

Yongin severance hospital,Yonsei university college of medicine

Locations

Yongin Severance hospital, Yonsei university college of medicine

Gyeonggi-do, Yongin-si, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Chang Ki Jang

Role: CONTACT

changgeejang@yuhs.ac

82-031-5189-8484

Facility Contacts

Chang Ki Jang

Role: primary

changgeejang@yuhs.ac

82-031-5189-8484

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

S6700

Identifier Type: -

Identifier Source: org_study_id