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

Cerebral Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945563
• Other study ID #: 120.VAS.2022.D
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: December 17, 2025

Study information

• Verified date: November 2023
• Source: Methodist Health System
• Contact: Colette N Ndjom, MS
• Phone: 214-947-1280
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: December 17, 2025
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registry Evaluation	The demographic characteristics, treatment strategies, incidence, and outcomes in patients hyper-responsive to clopidogrel.	90 days