An observational study in Platelet Dysfunction, sponsored by The University of The West Indies. Completed at 1 site in Trinidad and Tobago. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by The University of The West Indies · Observational
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.
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.
The University of The West Indies is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a cross-sectional, open-label (Plavix, Sanofi SA, Gentilly, France, Bristol-Myers Squibb, New York, USA) pilot study aimed to assess high on-treatment platelet reactivity which occurred during the period September 2017 to January 2018. Patients were screened with a stratified permuted block randomization technique which applied to both recruitment days (Monday, Tuesday and Thursday) and patients enrolled at the cardiac catheterization laboratory (cardiac bays 1 to 4) at the investigator's institution (Eric Williams Medical Sciences Complex, Trinidad and Tobago). The clinical research associates were blinded to the allocation assignment and randomization sequence numbers were obtained from SPSS version 24.0 software (IBM SPSS Statistics, New York City, New York, USA). On average, 1-2 patients were enrolled every week for 8 months.
Exclusion Criteria:
Patients who were on long-term (more than 3 months) of clopidogrel or received a loading dose more than 4 hours prior to elective percutaneous coronary intervention.
Overall prevalence of HPR in the Trinidadian population undergoing elective percutaneous coronary intervention
Time frame: 4 months
Prevalence of HPR in the South Asian Trinidadian population undergoing elective percutaneous coronary intervention
Time frame: 4 months
Plan to share: Yes — All information will be shared with requesting parties.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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The University of The West Indies