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Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction. (OCTIVUS)

1 september 2014 bijgewerkt door: Mikkel Hougaard, Odense University Hospital

The Effect Of Ezetimibe In Addition To Optimal Cholesterol-Lowering Statin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction - Assessed By Optical Coherence Tomography And Intravascular Ultrasound.

The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe when used in addition to optimal treatment with Atorvastatin in patients with acute ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.

An area with arteriosclerosis not demanding intervention in a coronary vessel other than the infarct related is used as measuring point and is examined at time of the infarction and after 12 month using intravascular ultrasound and optical coherence tomography. At the same time the same techniques are used to examine the implanted stent.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) with tissue characterization (IVUS-TC) are relatively new expansions to intravascular assessments, and has the capacity to assess plaque composition and, potentially, to identify vulnerable plaques. One of the mechanisms by which statins improve patient outcomes may be by changing the composition of a "vulnerable" plaque. The main effect is believed to rely on a lowering of LDL-c. The question is whether a further reduction of LDL by adding ezetimibe to optimal cholesterol lowering therapy using statins may result in further plaque stabilization or reduction. This is the hypothesis of the current study.

100 patients are randomized to Ezetimibe 10 mg per day or placebo. All patients are treated with Atorvastatin 80 mg. OCT and IVUS are performed at inclusion (typically the day after Primary PCI) and again at follow-up after 12 month.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

87

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Odense C, Denemarken, 5000
        • Department of Cardiology, Odense University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 81 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • ST segment elevation acute myocardial infarction
  • 20% < angiographic diameter stenosis < 50% on a not previously revascularized native coronary artery
  • Statin naïve
  • In fertile women: Ongoing contraception with IUD or hormonal contraception.

Exclusion Criteria:

  • Pharmacologic lipid lowering treatment before index hospitalization
  • Atrial fibrillation, not well rate-controlled
  • Ventricle frequency variation with more than a factor 2 over 1 minute
  • Unconscious patients
  • History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins) including Atorvastatin.
  • Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin [Beta-HCG] analysis)
  • History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears
  • Uncontrolled hypothyroidism (TSH > 1.5xULN)
  • Abnormal LFT's
  • History of alcohol or drug abuse within the last 5 years (this may affect compliance)
  • Current active liver disease (ALT/SGPT >2xULN or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins)
  • Unexplained creatine kinase (CK > 3xULN) (To protect patient safety) (will be increased at baseline because of acute ST segment elevation myocardial infarction a few days before enrolment)
  • Serum creatinine >176mmol/L (2.0mg/dL) (unless the protocol specifically aims to investigate a chronic renal disease population)
  • Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events)
  • Treatments with cyclosporine
  • Treatment with gemfibrozil

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Atorvastatin plus Placebo
50/100 patients are randomized to Atorvastatin 80 mg per day plus placebo.
Geneesmiddel: Placebo
100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
Andere namen:
  • Ezetrol
  • Zarator
Experimenteel: Atorvastatin plus Ezetimibe
100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
Geneesmiddel: Ezetimibe
100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
Andere namen:
  • Ezetrol
  • Zarator

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plaque volume and composition in a non-significant coronary plaque
Tijdsspanne: After 12 months of follow-up
Plaque volume assessed by intravascular ultrasound and Optical Coherence Tomography
After 12 months of follow-up

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in plaque-composition (measured with Tissue Characterization) in a 10 mm segment of a native coronary vessel with a non-significant stenosis where plaque-volume at baseline is greatest.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Change in percent of the plaque volume in the native coronary vessel with a non-significant stenosis.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Change in percent of the plaque volume in the 10 mm segment of a native coronary vessel with a non-significant lesion where plaque volume at baseline is greatest.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Change in absolute numbers of the plaque volume in the 10 mm segment of a native coronary vessel with a non-significant lesion where plaque volume at baseline is greatest.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Change in percent of the plaque burden in the 10 mm segment of a native coronary vessel with a non-significant lesion where plaque volume at baseline is greatest.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Change in percent of the plaque burden in a native coronary vessel with a non-significant lesion.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Incomplete stent apposition.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Edge response in stented segment.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Stent expansion.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Evaluation of the OCT-technique in clinical use compared to IVUS.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up
Evaluation of the Resolute stents effect on neointima growth and apposition.
Tijdsspanne: After 12 months of follow-up
After 12 months of follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Odense University Hospital

Onderzoekers

  • Hoofdonderzoeker: Mikkel Hougaard, MD, Department of Cardiology, Odense University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2011

Primaire voltooiing (Werkelijk)

1 juni 2014

Studie voltooiing (Werkelijk)

1 september 2014

Studieregistratiedata

Eerst ingediend

28 juni 2011

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2011

Eerst geplaatst (Schatting)

30 juni 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

3 september 2014

Laatste update ingediend die voldeed aan QC-criteria

1 september 2014

Laatst geverifieerd

1 september 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • OUH-OCTIVUS

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