- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667066
clOpidogrel "resIstaNce" in a Selected Population of Patients at a Tertiary Cardiovascular Center in Trinidad (POINT)
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
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North
-
Port Of Spain, North, Trinidad and Tobago, 00000
- Eric Williams Medical Sciences Complex
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- above 18 years of age
- diagnosed with stable angina awaiting elective coronary angiography on dual antiplatelet therapy for at least 3 months with aspirin 81 mg per day maintenance dose and "brand name" clopidogrel 75 mg per day maintenance dose
Exclusion Criteria:
- generic clopidogrel, i.e. not "brand name,"
- recent acute coronary syndrome within 6 months
- active bleeding
- prior cerebrovascular event
- clinical instability after an index event
- use of an oral anticoagulation agent (coumadin derivative or other anticoagulant therapy (such as dabigatran, rivaroxaban or apixaban)
- platelet count < 100 x 106/µL
- hemoglobin < 10 g/dL
- serum creatinine > 2.5 mg/dL
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall prevalence of HPR in the Trinidadian population undergoing elective percutaneous coronary intervention
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of HPR in the South Asian Trinidadian population undergoing elective percutaneous coronary intervention
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Naveen A Seecheran, MBBS MSc, The University of the West Indies
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEC057/11/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Platelet Dysfunction
-
Aggredyne, Inc.CompletedPlatelet Dysfunction Due to Aspirin IngestionUnited States
-
The University of The West IndiesCompletedPlatelet DysfunctionTrinidad and Tobago
-
IRCCS San RaffaeleCompleted
-
Ferring PharmaceuticalsCompletedPlatelet DysfunctionGermany
-
University of Lausanne HospitalsCompleted
-
Aggredyne, Inc.CompletedRisk Factor, Cardiovascular | Platelet Dysfunction Due to Drugs
-
Etablissement Français du SangUniversity of MarseilleCompleted
-
University Hospital, ToulouseCompletedPlatelet DysfunctionFrance
-
BRADEN DULONGRecruitingCardiopulmonary Bypass | Platelet DysfunctionCanada
-
The University of The West IndiesRecruiting
Clinical Trials on Clopidogrel
-
Korea University Anam HospitalCompleted
-
Chinese PLA General HospitalUnknownCLOPIDOGREL, POOR METABOLISM of (Disorder)China
-
Ospedale San DonatoCompletedAcute Myocardial InfarctionItaly
-
University of PecsTerminatedStable Angina Pectoris | Ad Hoc Percutaneous Coronary InterventionHungary
-
Hospital Central San Luis Potosi, MexicoUnknownAcute Coronary Syndrome
-
University of North Carolina, Chapel HillCompleted
-
Lady Reading Hospital, PakistanPakistan Chest Society, PakistanRecruitingCOPD | COPD Exacerbation AcutePakistan
-
Deutsches Herzzentrum MuenchenTerminatedCoronary Artery DiseaseGermany
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaCompleted