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NIRS Ticagrelor Evaluation

11. marts 2021 opdateret af: Medstar Health Research Institute

The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy

The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction in the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation in patients already on long-term statin therapy undergoing non-urgent PCI. It is hypothesized that the treatment with ticagrelor following PCI will lead to a significant 20% reduction in the lipid pool as measured by NIRS/IVUS at follow-up when compared with baseline imaging, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Single-Center, open-label study of the effect of ticagrelor on the reduction in the lipid pool in 30 patients with multi-vessel CAD 2 Treatment periods over 6 months, with 2 additional follow-up phone calls at 1 and 3 months.

Non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline and 6 month follow up A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS.

Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.

Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up.

Inclusion Criteria:

  • Female (post menopausal or surgically sterile) and/or male aged 18 years or older
  • Multi-vessel coronary artery disease
  • Statin therapy for minimum of 6 weeks prior to enrollment in the study with no plan for further adjustment
  • Non-emergent PCI for ACS with stent placement requiring dual-antiplatelet therapy
  • Ability to safely perform NIRS/IVUS for a concomitant non-culprit lesion with diameter stenosis ≥ 50% that was not treated with PCI
  • Willing and able to sign informed consent and participate in follow-up

Exclusion Criteria:

  • Thienopyridine or ticagrelor use in the last month
  • Need for coronary artery bypass surgery or other surgeries during the follow-up period
  • Documented medication non-compliance
  • Chronic inflammatory disorder or treatment with anti-inflammatory or immunosuppressive drugs
  • Prior or current malignancy within the last 5 years
  • Concomitant severe illness or reduced life expectancy that will prevent follow-up cardiac catheterization
  • Active infection
  • Pregnant or lactating women
  • End-stage renal disease
  • History of intracranial hemorrhage
  • Active pathological bleeding
  • Known sever hepatic impairment
  • Known hypersensitivity to ticagrelor

Study Procedures:

After consent is obtained non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline is performed and once again at 6 month follow up. A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS. Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up. There will be 1 month phone follow up, 3 month phone follow up and a 6 month clinical follow up that includes collecting blood, repeat catheterization, and repeat NIRS/IVUS procedure.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 4

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:

  • • Female (post menopausal or surgically sterile) and/or male aged 18 years or older

    • Multi-vessel coronary artery disease CAD
    • Statin therapy for minimum of 6 weeks prior to enrollment in the study with no plan for further adjustment
    • Non-emergent PCI for ACS with stent placement requiring dual-antiplatelet therapy
    • Ability to safely perform NIRS/IVUS for a concomitant non-culprit lesion with diameter stenosis ≥50% that was not treated with PCI
    • Willing and able to sign informed consent and participate in follow-up

Exclusion Criteria:

  • Thienopyridine or ticagrelor use in the last month
  • Need for coronary artery bypass surgery or other surgeries during the follow-up period
  • Documented medication non-compliance
  • Chronic inflammatory disorder or treatment with anti-inflammatory or immunosuppressive drugs
  • Prior or current malignancy within the last 5 years
  • Concomitant severe illness or reduced life expectancy that will prevent follow-up cardiac catheterization
  • Active infection
  • Pregnant or lactating women
  • End-stage renal disease
  • History of intracranial hemorrhage
  • Active pathological bleeding
  • Known severe hepatic impairment
  • Known hypersensitivity to ticagrelor

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patiens Discharged on Ticagrelor
Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.
Medicin: Ticagrelor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
Tidsramme: 6 months
Treatment with ticagrelor following PCI will lead to significant 20% reduction in the LCBI as assessed at follow up by NIRS/IVUS when compared with baseline imaging data of the reference vessel, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor
Tidsramme: 6 months
We expect to see a significant reduction of inflammatory markers of Hs-CRP, MCP-1, IL-1, IL-6, IL-18, and TNF- α as well as an increase in IL-10, a cytokine associated with a reduction in inflammation, following therapy with ticagrelor when compared with baseline values. This is expected as inflammatory markers should be lower in stable coronary artery disease compared with patients presenting with ACS. While there is no control group in the proposed study, it will be important to assess whether changes in established biomarkers associated with inflammation correlate with changes in LCBI. While ticagrelor was not shown to reduce inflammatory biomarkers to a greater degree than clopidogrel, it will be important to assess whether the reduction in LCBI is independent of or associated with reductions in inflammatory markers or platelet reactivity.
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Medstar Health Research Institute

Samarbejdspartnere

AstraZeneca

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. juni 2014

Primær færdiggørelse (Faktiske)

1. april 2016

Studieafslutning (Faktiske)

1. april 2016

Datoer for studieregistrering

Først indsendt

15. oktober 2014

Først indsendt, der opfyldte QC-kriterier

31. oktober 2014

Først opslået (Skøn)

4. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AZ_ISSBRIL0304

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Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med Ticagrelor

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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