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Effect of Celecoxib on Markers of Vascular Inflammation

16. september 2011 opdateret af: University of Florida

A Pilot Study to Determine the Effect of Celecoxib on Markers of Inflammation in Patients With Hypertension and Coronary Artery Disease

This study involves a drug called celecoxib, which is commonly prescribed for people with arthritis. Arthritis is caused by inflammation of the joints or tissues. Inflammation also occurs in the blood vessels that lead to your heart, and the purpose of this study is to see if celecoxib can reduce the blood vessel inflammation associated with high cholesterol and heart disease.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Chronic inflammation of the blood vessel wall is a hallmark of atherosclerosis. Elevated levels of low-density lipoprotein cholesterol (LDL-C), as well as blood pressure are known to be proinflammatory. Recent information suggests that acute ischemic events are associated with exacerbations in inflammation. Some data suggest that aspirin use is associated with suppression of markers of inflammation, and this response has been linked with improved outcome. Similarly, HMG Co-A Reductase inhibitors clearly reduce adverse outcomes in patients with atherosclerosis and recently, HMG Co-A Reductase inhibitor use has also been linked to reduction in inflammation. Due to the strong association of atherogenesis and plaque stability with inflammation, C-Reactive Protein (CRP), a marker of inflammation, has been evaluated as a potential tool for clinicians to assess cardiovascular risk, and has been found to be highly correlated. There is also evidence to suggest that cyclooxygenase 2 (COX-2) enzyme is expressed in plaque at regions which are vulnerable to rupture. Accordingly, this study is designed to investigate the potential reduction in vascular inflammation from a specific COX-2 inhibitor, celecoxib, as measured by a reduction from baseline of CRP, interleukin-6 (IL-6) and tumor necrosis factor - alpha (TNF-alpha). This is a double blind, placebo controlled pilot study in hypertensive patients with coronary artery disease and dyslipidemia, to evaluate the effect of celecoxib versus placebo on inflammatory markers. Patients will receive study drug for three months.

Undersøgelsestype

Interventionel

Tilmelding

75

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida
    • Texas
      • Houston, Texas, Forenede Stater
        • University of Texas Health Science 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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age greater than or equal to 50 years old
  • Hypertension documented and treated according to the 6th report of the Joint National Committee on Detection and Evaluation of the treatment of high blood pressure (JNC VI)
  • Documented coronary artery disease, defined as classic stable angina pectoris, previous myocardial infarction (more than 1 month ago) or unstable angina (more than 1 month ago), abnormal coronary angiogram, or concordant abnormalities on two different types of stress tests
  • Dyslipidemia requiring medical therapy with HMG CoA Reductase inhibitors, and treated according to NCEP II guidelines for cholesterol lowering
  • Diabetes, if treated according to ADA guidelines for diabetes
  • Classic angina, if treated according to ACC/AHA guidelines for angina control
  • Therapy with an HMG CoA Reductase inhibitor for at least 3 months
  • Willingness to provide informed consent

Exclusion Criteria:

  • PUD
  • Coronary Artery Bypass Surgery or PTCA in the past 6 months
  • Active infection
  • Weight < 50Kg
  • History of a hematologic bleeding disorder
  • History of gastrointestinal bleeding
  • Allergy to aspirin or celecoxib or other NSAIDs or sulfonamides
  • Allergy or intolerance to HMG CoA Reductase inhibitor therapy
  • Stroke within 1 month of enrollment
  • History of a chronic inflammatory disease
  • History of asthma
  • History of hepatic disorder
  • Advanced renal disease (Serum Creatinine > 3mg/dl)
  • Anticipated need for therapy with NSAIDs within the 3 month period of the study
  • Chronic therapy (14 consecutive days) with any NSAID in the last 30 days

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: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Change in CRP

Sekundære resultatmål

Resultatmål
Change in IL6
Change in TNF alpha
Change in BP
Change in indices of vascular function (FMD and vascular compliance)

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Rhonda M Cooper-DeHoff, Pharm D, University of Florida Faculty

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. juli 2002

Studieafslutning (Faktiske)

1. december 2004

Datoer for studieregistrering

Først indsendt

7. maj 2007

Først indsendt, der opfyldte QC-kriterier

8. maj 2007

Først opslået (Skøn)

9. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2011

Sidst verificeret

1. maj 2007

Mere information

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 .

Kliniske forsøg med Hypertension and Coronary Artery Disease

Kliniske forsøg med placebo

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