NCT05945563

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2025

Completed
Last Updated

March 27, 2024

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

July 6, 2023

Last Update Submit

March 26, 2024

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Registry Evaluation

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

    90 days

Eligibility Criteria

Age18 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale and Male age 18 or older
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 16490830BACKGROUND

  • 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.

    PMID: 17130347BACKGROUND

  • 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.

    PMID: 22183178BACKGROUND

  • 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.

    PMID: 12270003BACKGROUND

  • 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.

    PMID: 12719773BACKGROUND

  • 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.

    PMID: 15653023BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Central Study Contacts

Colette N Ndjom, MS

CONTACT

214-947-1280MHSIRB@mhd.com

Loretta W Bedell

CONTACT

214-947-4680mhsirb@mhd.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

January 17, 2023

Primary Completion

January 17, 2025

Study Completion

December 17, 2025

Last Updated

March 27, 2024

Record last verified: 2023-11

Locations

US(1)