Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03667066
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2018-09-07
Brief Title:
clOpidogrel resIstaNce in a Selected Population of Patients at a Tertiary Cardiovascular Center in Trinidad
Sponsor:
The University of The West Indies
Organization:
The University of The West Indies
Study Overview
Official Title:
Prevalence of clOpidogrel resIstaNce in a Selected Population of Patients Undergoing Elective Percutaneous Coronary Intervention at a Tertiary Cardiovascular Center in Trinidad The POINT Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POINT
Brief Summary:
The aim of this study was to determine the prevalence of clopidogrel resistance among a selected group of patients undergoing elective percutaneous coronary intervention and to observe whether there was any south-Asian Indo-Trinidadian predilection for HPR considering the well-established epidemiologic trends for accelerated CAD within this subgroup
Detailed Description:
Clopidogrel a second generation oral thienopyridine remains an integral component of dual antiplatelet therapy DAPT in the management of cardiovascular disease CVD for almost two decades Several studies underscore the importance of high on-treatment platelet reactivity HPR as a prognosticator for cardiovascular events including stent thrombosis This phenomenon is often alluded to as clopidogrel resistance and yet to be clearly defined Generally it reflects the failure to achieve its antiaggregatory effect Clopidogrel response is both complex and multifactorial determined by a multitude of intrinsic and extrinsic mechanisms including genetic polymorphisms of the P2Y12 receptor drug-drug interactions and clinical factors such as suboptimal dosing regimens acute coronary syndromes diabetes mellitus and possibly smoking
High pre-treatment platelet reactivity may lead to mitigated clopidogrel-induced antiplatelet effects and are more commonly observed in specific clinical scenarios such as ACS increased body mass index and diabetes mellitus in particular insulin-dependent diabetes mellitus Matetzky et al also surmised that nearly one-quarter of ST-segment elevation acute coronary syndrome patients would incur stent thrombosis due to this phenomenon
Overall HPR prevalence in various studies is estimated at 5-44 however these are based on largely Caucasian populations and yet to be ascertained in a Caribbean subpopulation Trinidad and Tobago has an ethnically diverse population with approximately one-third South Asian Indo-Trinidadian one-third Caribbean Black Afro-Trinidadian and the remaining one-third mostly interracial and mixed CVD is currently the leading cause of mortality in Trinidad and Tobago accounting for up to 60 of all deaths annually
High pre-treatment platelet reactivity may lead to mitigated clopidogrel-induced antiplatelet effects and are more commonly observed in specific clinical scenarios such as ACS increased body mass index and diabetes mellitus in particular insulin-dependent diabetes mellitus Matetzky et al also surmised that nearly one-quarter of ST-segment elevation acute coronary syndrome patients would incur stent thrombosis due to this phenomenon
Overall HPR prevalence in various studies is estimated at 5-44 however these are based on largely Caucasian populations and yet to be ascertained in a Caribbean subpopulation Trinidad and Tobago has an ethnically diverse population with approximately one-third South Asian Indo-Trinidadian one-third Caribbean Black Afro-Trinidadian and the remaining one-third mostly interracial and mixed CVD is currently the leading cause of mortality in Trinidad and Tobago accounting for up to 60 of all deaths annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None