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Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus (OCELOT)

6. november 2014 opdateret af: Policlinico Casilino ASL RMB

Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens

Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.

Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months.

Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12 months) of dual antiplatelet therapy

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Undersøgelsestype

Interventionel

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
      • Modena, Italien, 41100
        • Azienda Policlinico-Universitaria di Modena
      • Rome, Italien, 00100
        • Policlinico Casilino

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subject is > 18 years old
  2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent
  3. Subject and the treating physician agree that the subject will comply with all follow-up evaluations
  4. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

  1. Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure
  2. The patient is pregnant or breastfeeding
  3. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated)
  4. A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3
  5. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  6. Prior participation in this study
  7. Active peptic ulcer or upper GI bleeding within the prior 3 months
  8. Subject has active sepsis
  9. Any lesion that is located in a saphenous vein graft
  10. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Taxus Element
Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
Enhed: Taxus Element stent
paclitaxel-eluting stent
Andre navne:
  • Taxus
Aktiv komparator: Xience Prime
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
Enhed: Xience Prime stent
Everolimus-eluting stent
Andre navne:
  • Xience Prime
Aktiv komparator: Integrity Resolute
Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
Enhed: Integrity Resolute stent
ABT 578-eluting stent
Andre navne:
  • Resolut integritet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target lesion failure
Tidsramme: 1 year
Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of glucose levels on repeat revascularization
Tidsramme: 1 year
Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
1 year
Target Lesion Revascularization
Tidsramme: 1, 2 and 3 year
Target lesion revascularization at 12, 24 and 36 months
1, 2 and 3 year
Effect of dual antiplatelet therapy on outcome
Tidsramme: 3 year
Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome
3 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Policlinico Casilino ASL RMB

Samarbejdspartnere

Azienda Ospedaliero-Universitaria di Modena

Efterforskere

  • Ledende efterforsker: Enrico Romagnoli, MD, PhD, Policlinico Casilino

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

10. februar 2011

Først indsendt, der opfyldte QC-kriterier

10. februar 2011

Først opslået (Skøn)

11. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2014

Sidst verificeret

1. august 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 007/CE-RMB

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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