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

Primary Purpose

Intracranial Aneurysm

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prasugrel group
Clopidogrel group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm, Clopidogrel, Prasugrel Hydrochloride

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yongin Severance hospital, Yonsei university college of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clopidogrel

prasugrel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
bleeding safety endpoint
major and minor bleeding within 30days after procedure :: incidence of treatment-major and minor bleeding

Full Information

First Posted
January 9, 2022
Last Updated
July 13, 2022
Sponsor
Yonsei University
Collaborators
Severance Hospital, Gangnam Severance Hospital, Bucheon St. Mary's Hospital, International St. Mary's Hospital, Ewha Woman's University Seoul Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05359224
Brief Title
Low Dose Prasugrel vs Clopidogrel for Stenting or Flow Diverter for Unruptured Aneurysm
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
Collaborators
Severance Hospital, Gangnam Severance Hospital, Bucheon St. Mary's Hospital, International St. Mary's Hospital, Ewha Woman's University Seoul Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Intracranial Aneurysm, Clopidogrel, Prasugrel Hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
prasugrel
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prasugrel group
Other Intervention Name(s)
effient
Intervention Description
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
Intervention Name(s)
Clopidogrel group
Other Intervention Name(s)
plavix
Intervention Description
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.
Primary Outcome Measure Information:
Title
peri-procedural thromboembolic complications
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
thromboembolic safety endpoint
Description
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.
Time Frame
30days
Title
bleeding safety endpoint
Description
major and minor bleeding within 30days after procedure :: incidence of treatment-major and minor bleeding
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Ki Jang
Phone
82-031-5189-8484
Email
changgeejang@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Ki Jang
Organizational Affiliation
Yongin severance hospital,Yonsei university college of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Yongin Severance hospital, Yonsei university college of medicine
City
Gyeonggi-do
State/Province
Yongin-si
ZIP/Postal Code
16995
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Ki Jang
Phone
82-031-5189-8484
Email
changgeejang@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Keun Young Park

12. IPD Sharing Statement

Plan to Share IPD
No

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

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