- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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North
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Port Of Spain, North, Trinidad og Tobago, 00000
- Eric Williams Medical Sciences Complex
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Overall prevalence of HPR in the Trinidadian population undergoing elective percutaneous coronary intervention
Tidsramme: 4 months
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4 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Prevalence of HPR in the South Asian Trinidadian population undergoing elective percutaneous coronary intervention
Tidsramme: 4 months
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4 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Naveen A Seecheran, MBBS MSc, The University of The West Indies
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CEC057/11/15
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Clopidogrel
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Chinese PLA General HospitalUkendtCLOPIDOGREL, DÅRLIG METABOLISME af (lidelse)Kina
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Korea University Anam HospitalAfsluttet
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Fondation Hôpital Saint-JosephIkke rekrutterer endnuCLTI defineret som Rutherford kategori 4 eller 5
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Ospedale San DonatoAfsluttet
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University of PecsAfsluttetStabil Angina Pectoris | Ad hoc perkutan koronar interventionUngarn
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University of North Carolina, Chapel HillAfsluttet
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Hospital Central San Luis Potosi, MexicoUkendtAkut koronarsyndrom
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Deutsches Herzzentrum MuenchenAfsluttetKoronararteriesygdomTyskland
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Lady Reading Hospital, PakistanPakistan Chest Society, PakistanRekrutteringKOL | KOL-eksacerbation AkutPakistan