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

NCT05359224 | Unknown Phase 4

• 1 other identifier: S6700
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysm; Clopidogrel; Prasugrel Hydrochloride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• thromboembolic safety endpoint

  30days

• bleeding safety endpoint

  30days

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

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

prasugrel

ACTIVE COMPARATOR

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

Interventions

Prasugrel group 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.

Also known as: effient

prasugrel

Clopidogrel group 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.

Also known as: plavix

Clopidogrel

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ∙ 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

Sponsors & Collaborators

• Yonsei University: lead
• Severance Hospital: collaborator
• Gangnam Severance Hospital: collaborator
• Bucheon St. Mary's Hospital: collaborator
• International St. Mary's Hospital: collaborator
• Ewha Woman's University Seoul Hospital: collaborator

Study Sites (1)

Yongin Severance hospital, Yonsei university college of medicine

Gyeonggi-do, Yongin-si, 16995, South Korea

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chang Ki Jang

  Yongin severance hospital,Yonsei university college of medicine

  STUDY DIRECTOR

Central Study Contacts

Chang Ki Jang

CONTACT

82-031-5189-8484; changgeejang@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: May 3, 2022
• Study Start: June 13, 2022
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)