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Continuous Clopidogrel Dose Adjustment in Acute Coronary Syndrome Patients With High On-treatment Platelet Reactivity

14. august 2014 oppdatert av: Jure Samardzic, University of Zagreb

Effect of Continuous Clopidogrel Dosing Targeted After Platelet Function Testing in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention With High On-treatment Platelet Reactivity

The purpose of this study is to determine whether continuous clopidogrel dose adjustment targeted after platelet function testing improves outcomes during 12 months of follow-up in acute coronary syndrome patients treated with coronary artery stenting and with determined high platelet reactivity on clopidogrel.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dual antiplatelet therapy (DAPT) with aspirin and P2Y12 receptor antagonists during 12 months presents cornerstone treatment in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Clopidogrel is the most widely used P2Y12 inhibitor despite it's limitations that include highly variable P2Y12-receptor inhibition which causes wide interindividual platelet reactivity variability. Since high on-treatment platelet reactivity (HTPR) on clopidogrel is strongly associated with adverse events, antiplatelet therapy tailoring has been vastly investigated to determine whether individualized approach could improve outcomes. In the time of progressive personalized approach to therapy, effective strategies are needed to minimize the risk of ischemic adverse events without increasing the risk for bleeding.

Aim of this study is to investigate whether continuous clopidogrel dose adjustment according to platelet function testing (PFT) using Multiplate® function analyzer (Roche Diagnostics, Mannheim, Germany) could decrease the rate of adverse events in ACS patients treated with PCI and with HTPR during early and late period of DAPT treatment.

Cut off values for HTPR and enhanced platelet response were set according to the consensus statement at >46 U and <19 U, respectively. PFT and therapy tailoring was performed at day 1, 2, 3, 7, 30 and month 2, 3, 6, 9 and 12.

Studietype

Intervensjonell

Registrering (Faktiske)

87

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kroatia
      • Zagreb, Kroatia, 10000
        • University Hospital Centre Zagreb

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • acute coronary syndrome patients treated with successful PCI
  • age 18-80 years
  • determined high on-treatment platelet reactivity

Exclusion Criteria:

  • continuous postinterventional glycoprotein (GP) IIbIIIa receptor inhibitor infusion
  • thrombocytopenia (<150x109/L)
  • significant renal insufficiency (creatinine>200 µmol/L)
  • anemia (Htc<30%)
  • hemorrhagic diathesis
  • history of intracranial bleeding or ischemic cerebrovascular insult 6 months before
  • major operation 6 weeks before
  • concomitant chronic anticoagulation therapy
  • age <18 years and >80 years

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: control group
Patients in this group will receive standard clopidogrel dose
Eksperimentell: interventional group

Patients in the interventional arm will receive clopidogrel dose adjustment to maintain optimal platelet reactivity determined by Multiplate function analyzer (19-46U).

They will undergo platelet function testing on day 1,2,3,7,30 and month 2,3,6,9 and 12.

On first two measurements patients will receive up to 2 additional clopidogrel loading doses (600 mg) and put on 150 mg and 75 mg a day if platelet reactivity >18U and <18U, respectively. Maintenance dose will be determined on following measurements - increased by 75 mg if >46U; not changed if 19-46U; decreased by 75 mg if <19U. Minimal dose - 75 mg; maximal dose 300 mg (for patients >70 years 150 mg)
Legemiddel: Clopidogrel dose adjustment

Patients in the interventional arm will receive clopidogrel dose adjustment to maintain optimal platelet reactivity determined by Multiplate function analyzer (19-46U).

They will undergo platelet function testing on day 1,2,3,7,30 and month 2,3,6,9 and 12.

On first two measurements patients will receive up to 2 additional clopidogrel loading doses (600 mg) and put on 150 mg and 75 mg a day if platelet reactivity >18U and <18U, respectively. Maintenance dose will be determined on following measurements - increased by 75 mg if >46U; not changed if 19-46U; decreased by 75 mg if <19U. Minimal dose - 75 mg; maximal dose 300 mg (for patients >70 years 150 mg)

Andre navn:
  • antiplatelet therapy tailoring

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
clinical outcome - composite endpoint of total cardiovascular death, non-fatal myocardial infarction, target vessel revascularization and ischemic stroke
Tidsramme: 12 months
Data will be collected during the entire follow up period on interviews and analyzing patient medical data.
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
number of bleeding events
Tidsramme: 12 months

BARC classification (Bleeding Academic Research Consortium)

  • Type 0: no evidence of bleeding
  • Type 1: bleeding without need for hospitalization or treatment (e.g. bruising, hematoma, nosebleeds, etc.)
  • Type 2: any clinically overt sign of hemorrhage that is actionable but does not meet criteria for type 3, 4 or 5.
  • Type 3: clinical, laboratory, and/or imaging evidence of bleeding, with healthcare provider responses
  • Type 4: Coronary Artery Bypass Graft-related bleeding
  • Type 5: Fatal bleeding
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Zagreb

Samarbeidspartnere

Clinical Hospital Centre Zagreb
Ministry of Science, Education and Sport, Republic of Croatia

Etterforskere

  • Studiestol: Davor Milicic, MD, PhD, University of Zagreb School of Medicine
  • Hovedetterforsker: Jure Samardzic, MD, University of Zagreb School of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2012

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først innsendt

19. mars 2014

Først innsendt som oppfylte QC-kriteriene

22. mars 2014

Først lagt ut (Anslag)

26. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. august 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2014

Sist bekreftet

1. august 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 108-1081875-1993-1

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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