Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI) (PRO-GR-4)

29. september 2011 oppdatert av: Dimitrios Alexopoulos, University of Patras

Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)and Presenting With High Platelet Reactivity, as Assessed With a Point of Care Assay, After 600mg Clopidogrel Loading Dose

This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention and presenting high platelet reactivity as assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2 hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:

Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day starting from Day 1 until Day 5 (5 days after randomization).

Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.

Studieoversikt

Status

Fullført

Forhold

Studietype

Intervensjonell

Registrering (Forventet)

35

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

      • Patras, Hellas, 26500
        • Patras University Hospital

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 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients with STEMI undergoing primary PCI with stenting
  3. Platelet reactivity in PRU ≥235 2 hours post 600 mg clopidogrel loading dose
  4. Informed consent obtained in writing

Exclusion Criteria:

  1. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 5.
  2. Pregnancy
  3. Breastfeeding
  4. Inability to give informed consent or high likelihood of being unavailable until Day 5.
  5. Cardiogenic shock
  6. Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
  7. Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
  8. Requirement for oral anticoagulant prior to the Day 5
  9. Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
  10. Known hypersensitivity to prasugrel or ticagrelor
  11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
  13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  14. Thrombocytopenia (<100.000 / μL) at randomization
  15. Anaemia (Hct <30%) at randomization
  16. Polycythaemia (Hct > 52%) at randomization
  17. Periprocedural IIb/IIIa inhibitors administration
  18. Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
  19. Recent (< 6 weeks) major surgery or trauma, including GABG.
  20. Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
  21. INR>1.5 at randomization

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Prasugrel
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
Aktiv komparator: Clopidogrel
Clopidogrel 150mg/day starting from Day 1 until Day 5
Clopidogrel 150mg/d starting from Day 1

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Platelet reactivity
Tidsramme: 24 hours post randomization (Day 1)
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
24 hours post randomization (Day 1)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Platelet reactivity
Tidsramme: 2 hours post randomization (Day 0)
Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization
2 hours post randomization (Day 0)
Platelet reactivity
Tidsramme: 5 days post randomization (Day 5)
Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
5 days post randomization (Day 5)
Hyporesponsiveness rate
Tidsramme: 2 hours post randomization (Day 0)
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization
2 hours post randomization (Day 0)
Hyporesponsiveness rate
Tidsramme: 24 hours post randomization (Day 1)
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization
24 hours post randomization (Day 1)
Hyporesponsiveness rate
Tidsramme: 5 days post randomization (Day 5)
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization
5 days post randomization (Day 5)

Samarbeidspartnere og etterforskere

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

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. april 2011

Primær fullføring (Faktiske)

1. september 2011

Studiet fullført (Faktiske)

1. september 2011

Datoer for studieregistrering

Først innsendt

15. april 2011

Først innsendt som oppfylte QC-kriteriene

19. april 2011

Først lagt ut (Anslag)

20. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. september 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2011

Sist bekreftet

1. september 2011

Mer informasjon

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. .

Kliniske studier på Hjerteinfarkt

Kliniske studier på Prasugrel

Abonnere