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Ticagrelor vs Clopidogrel Effect on MFR in CAD Population (PATH)

21. april 2017 opdateret af: Terrence Ruddy, Ottawa Heart Institute Research Corporation

ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study

Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.

This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.

This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

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. Age ≥ 18 years old
  2. Stable coronary artery disease on stable medical treatment.
  3. BMI equal to or less than 30 kg/m2
  4. No clinically significant abnormalities in baseline laboratory work
  5. No clinically significant arrhythmias on baseline 12-lead electrocardiogram
  6. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment.

Exclusion Criteria:

  1. Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
  2. Oral anticoagulation therapy.
  3. History of intracranial bleeding.
  4. Recent or active pathological bleeding, such as peptic ulcer.
  5. Moderate or severe hepatic impairment.
  6. History or risk of bradycardia.
  7. Known second- or third-degree AV block without pacemaker
  8. Dyspnea (NYHA III/IV), wheezing asthma or COPD.
  9. Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent.
  10. Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent.
  11. Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent.
  12. Any scheduled surgery during the trial period, including dental.
  13. Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer.
  14. Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
  15. Known hypersensitivity to the investigational drug or any of its components.
  16. Known hypersensitivity to adenosine.
  17. Lactose intolerance
  18. Breastfeeding or pregnancy.
  19. Claustrophobia or inability to lie still in a supine position
  20. Unwillingness to provide informed consent

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: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: stable CAD management
Experimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day
Medicin: Ticagrelor
Blinded administration of ticagrelor for 10 days
Andre navne:
  • BrilintaTM
Medicin: Clopidogrel
Blinded administration of clopidogrel and placebo for 10 days
Aktiv komparator: CAD comparison group
Active comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day.
Medicin: Ticagrelor
Blinded administration of ticagrelor for 10 days
Andre navne:
  • BrilintaTM
Medicin: Clopidogrel
Blinded administration of clopidogrel and placebo for 10 days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET
Tidsramme: q 2 weeks blood flow measurements

Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated.

Actual study drug effect will not be known until the study has completed and the treatment unblinded.
q 2 weeks blood flow measurements

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects
Tidsramme: q 2 weeks blood flow measurements

Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure rest/stress MBF and myocardial blood flow reserve. The crossover to the other study arm will occur and the study procedure repeated.

Actual study drug effecting flow will not be known until the study has completed and the treatment unblinded.
q 2 weeks blood flow measurements

Samarbejdspartnere og efterforskere

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

Sponsor

Ottawa Heart Institute Research Corporation

Efterforskere

  • Ledende efterforsker: Terrence Ruddy, MD, Ottawa Heart Institute Research Corporation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 2013

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

27. februar 2013

Først indsendt, der opfyldte QC-kriterier

8. juli 2013

Først opslået (Skøn)

10. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20130105-01H

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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