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CompletedNCT03667066POINTUpdated Sep 27, 2018

clOpidogrel "resIstaNce" in a Selected Population of Patients at a Tertiary Cardiovascular Center in Trinidad

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

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Platelet Dysfunction
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In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • DrugClopidogrel

    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.

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What researchers measure

Primary outcomes

  1. Overall prevalence of HPR in the Trinidadian population undergoing elective percutaneous coronary intervention

    Time frame: 4 months

Secondary outcomes

  1. Prevalence of HPR in the South Asian Trinidadian population undergoing elective percutaneous coronary intervention

    Time frame: 4 months

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Study locations

1 site
  • Eric Williams Medical Sciences Complex
    Port Of Spain, North 00000, Trinidad and Tobago
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References and documents

Publications

  • Seecheran NA, Maharaj A, Boodhai B, Seecheran R, Seecheran V, Persad S, Ramsaroop K, Sandy S, Giddings S, Sakhamuri S, Ali R, Motilal S, Teelucksingh S, Tello-Montoliu A. Prevalence of clOpidogrel 'resIstaNce' in a selected population of patients undergoing elective percutaneous coronary intervention at a tertiary cardiovascular centre in Trinidad: the POINT pilot study. Open Heart. 2019 Feb 27;6(1):e000841. doi: 10.1136/openhrt-2018-000841. eCollection 2019. PubMed 30997117 ↗

Individual participant data

Plan to share: Yes — All information will be shared with requesting parties.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03667066
Lead sponsor
The University of The West Indies
Responsible party
Sponsor
First posted
Sep 12, 2018
Start date
Sep 1, 2017
Primary completion
Jan 1, 2018
Completion
Jun 1, 2018
Last update
Sep 27, 2018

Study contacts

Naveen A Seecheran, MBBS MSc
principal investigator · The University of The West Indies

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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