Clopidogrel Hyper-Responsiveness: Incidence and Associated Outcomes in Patients With Cerebral Aneurysms

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05945563
Collaborator
(none)
208
1
23
9

Study Details

Study Description

Brief Summary

This registry study will investigate the incidence of and outcomes associated with clopidogrel hyper-responsive patients treated at Methodist Dallas Medical Center, beginning in January 2018, who suffered cerebral aneurysms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This registry study will investigate the incidence of and outcomes associated with clopidogrel hyper-responsive patients treated at Methodist Dallas Medical Center, beginning in January 2018, who suffered cerebral aneurysms.

    Perioperative and short-term clinical data will be obtained from electronic medical records. All the data variables will be documented in an Excel sheet (Appendix B). This section will provide an overview of the data collected which will include, but are not limited to, the following:

    • Pre-Operative Information: Demographics (e.g., age, gender), patient characteristics (e.g., BMI, American Society of Anesthesiologists class), and pre-operative medical history (e.g., tobacco use; comorbidities: hypertension, cardiopulmonary disease, diabetes; etc.).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    208 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Clopidogrel Hyper-Responsiveness: Incidence and Associated Outcomes in Patients With Cerebral Aneurysms
    Actual Study Start Date :
    Jan 17, 2023
    Anticipated Primary Completion Date :
    Jan 17, 2024
    Anticipated Study Completion Date :
    Dec 17, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Registry Evaluation [90 days]

      The demographic characteristics, treatment strategies, incidence, and outcomes in patients hyper-responsive to clopidogrel.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Age 18 years or older Diagnosed with cerebral aneurysms (i.e. ICD-10 i67.1) Pre-intervention treatment with clopidogrel

    Exclusion Criteria:
    • Does not meet inclusion criteria specified in 3.1

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT05945563
    Other Study ID Numbers:
    • 120.VAS.2022.D
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2023