Clinical trial NCT05945563: Clopidogrel Hyper-Responsiveness: Incidence and Associated Outcomes in Patients With Cerebral Aneurysms
Official title: Clopidogrel Hyper-Responsiveness: Incidence and Associated Outcomes in Patients With Cerebral Aneurysms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Aneurysm
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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

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.

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.).

Eligibility 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

Primary outcomes:
measure: Registry Evaluation
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
References:
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citation: O'Donoghue M, Wiviott SD. Clopidogrel response variability and future therapies: clopidogrel: does one size fit all? Circulation. 2006 Nov 28;114(22):e600-6. doi: 10.1161/CIRCULATIONAHA.106.643171. No abstract available.
citation: Damman P, Woudstra P, Kuijt WJ, de Winter RJ, James SK. P2Y12 platelet inhibition in clinical practice. J Thromb Thrombolysis. 2012 Feb;33(2):143-53. doi: 10.1007/s11239-011-0667-5.
citation: Jaremo P, Lindahl TL, Fransson SG, Richter A. Individual variations of platelet inhibition after loading doses of clopidogrel. J Intern Med. 2002 Sep;252(3):233-8. doi: 10.1046/j.1365-2796.2002.01027.x.
citation: Muller I, Besta F, Schulz C, Massberg S, Schonig A, Gawaz M. Prevalence of clopidogrel non-responders among patients with stable angina pectoris scheduled for elective coronary stent placement. Thromb Haemost. 2003 May;89(5):783-7.
citation: Serebruany VL, Steinhubl SR, Berger PB, Malinin AI, Bhatt DL, Topol EJ. Variability in platelet responsiveness to clopidogrel among 544 individuals. J Am Coll Cardiol. 2005 Jan 18;45(2):246-51. doi: 10.1016/j.jacc.2004.09.067.