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

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ClinicalTrials.gov Identifier: NCT05945563
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Study Description
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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
Cerebral Aneurysm

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Clopidogrel Hyper-Responsiveness: Incidence and Associated Outcomes in Patients With Cerebral Aneurysms
Actual Study Start Date : January 17, 2023
Estimated Primary Completion Date : January 17, 2025
Estimated Study Completion Date : December 17, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Registry Evaluation [ Time Frame: 90 days ]
    The demographic characteristics, treatment strategies, incidence, and outcomes in patients hyper-responsive to clopidogrel.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female and Male age 18 or older
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age 18 years or older Diagnosed with cerebral aneurysms (i.e. ICD-10 i67.1) Pre-intervention treatment with clopidogrel
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945563


Contacts
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Contact: Colette N Ndjom, MS 214-947-1280 ext 71280 MHSIRB@mhd.com
Contact: Loretta W Bedell 214-947-4680 ext 74680 mhsirb@mhd.com

Locations
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United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Colette N Ndjom, MS    214-947-4681 ext 71280    mhsirb@mhd.com   
Contact: Loretta W Bedell, MPH    217-947-4680 ext 74680    mhsirb@mhd.com   
Principal Investigator: Bartley Mitchell, MD         
Sponsors and Collaborators
Methodist Health System
More Information
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Publications:
Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neil WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention). Circulation. 2006 Feb 21;113(7):e166-286. doi: 10.1161/CIRCULATIONAHA.106.173220. No abstract available.

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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT05945563    
Other Study ID Numbers: 120.VAS.2022.D
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases