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

NCT03667066 | Completed FDA Drug

• 1 other identifier: CEC057/11/15
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (1)

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

  4 months

Interventions

Clopidogrel DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

Eric Williams Medical Sciences Complex

Port of Spain, North, 00000, Trinidad and Tobago

Location

Related Publications (1)

• 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.

  PMID: 30997117 DERIVED

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Naveen A Seecheran, MBBS MSc

  The University of The West Indies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 12, 2018
• Study Start: September 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It will be openly available until 5 years after the completion of the study.
• Access Criteria: Please contact the Principal Investigator for the requested information.

Locations

TR (1)