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Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition (TRIAGE)

22. december 2015 opdateret af: Icahn School of Medicine at Mount Sinai

TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition

The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

318

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- New York
  - New York, New York, Forenede Stater, 10029
    - Mount Sinai Medical Center

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects in any of the participating sites who are on chronic clopidogrel treatment and return for PCI will be considered for this study.

Beskrivelse

Inclusion Criteria:

The subject has provided informed written.
The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
The subject is willing and able to cooperate with the study procedures and required follow-ups.

Exclusion Criteria:

Patients with cardiogenic shock will be excluded.
The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
Pregnant women.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kun etui
Tidsperspektiver: Fremadrettet

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
SA + 5mg prasugrel Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin.
ASA + 10 mg prasugrel Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin.
ASA + 75 mg clopidogrel daily Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age >75; Wt< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
MACE Tidsramme: 12 months	Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)	12 months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Rates of major bleeding Tidsramme: 12 months	The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.	12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Icahn School of Medicine at Mount Sinai

Samarbejdspartnere

Daiichi Sankyo, Inc.

Accumetrics, Inc.

Efterforskere

Ledende efterforsker: George Dangas, MD, Icahn School of Medicine at Mount Sinai

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. marts 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)