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

NCT05359224 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2022-07-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER
  • Gangnam Severance Hospital

    collaborator OTHER
  • Bucheon St. Mary's Hospital

    collaborator OTHER
  • International St. Mary's Hospital

    collaborator UNKNOWN
  • Ewha Woman's University Seoul Hospital

    collaborator UNKNOWN
  • Yonsei University

    lead OTHER

Principal Investigators

  • Chang Ki Jang · Yongin severance hospital,Yonsei university college of medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05359224 on ClinicalTrials.gov