clOpidogrel "resIstaNce" in a Selected Population of Patients at a Tertiary Cardiovascular Center in Trinidad (POINT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03667066|
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : September 27, 2018
|Condition or disease||Intervention/treatment|
|Platelet Dysfunction||Drug: Clopidogrel|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|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|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
- Drug: Clopidogrel
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667066
|Trinidad and Tobago|
|Eric Williams Medical Sciences Complex|
|Port Of Spain, North, Trinidad and Tobago, 00000|
|Principal Investigator:||Naveen A Seecheran, MBBS MSc||The University of The West Indies|