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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05359224

Collaborator

Severance Hospital (Other), Gangnam Severance Hospital (Other), Bucheon St. Mary's Hospital (Other), International St. Mary's Hospital (Other), Ewha Woman's University Seoul Hospital (Other)

406

Enrollment

Location

Arms

37.6

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Drug: Prasugrel group Drug: Clopidogrel group	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 13, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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. Other Names: plavix
Active Comparator: 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.	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. Other Names: effient

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Other Names:

plavix

Active Comparator: prasugrel

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.

Other Names:

effient

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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