- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00471341
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
Betingelser
Intervention / Behandling
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
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Gainesville, Florida, Forenede Stater, 32610
- University of Florida
-
-
Texas
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Houston, Texas, Forenede Stater
- University of Texas Health Science Center
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-
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.
Sponsor
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
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronararteriesygdom
- Myokardieiskæmi
- Koronar sygdom
- Forhøjet blodtryk
- Betændelse
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Cyclooxygenase 2-hæmmere
- Celecoxib
Andre undersøgelses-id-numre
- 219-2001
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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