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

1 de septiembre de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

87

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 81 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Atorvastatin plus Placebo
50/100 patients are randomized to Atorvastatin 80 mg per day plus placebo.
Droga: 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.
Otros nombres:
  • Ezetrol
  • Zarator
Experimental: 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.
Droga: 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.
Otros nombres:
  • Ezetrol
  • Zarator

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plaque volume and composition in a non-significant coronary plaque
Periodo de tiempo: After 12 months of follow-up
Plaque volume assessed by intravascular ultrasound and Optical Coherence Tomography
After 12 months of follow-up

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: After 12 months of follow-up
After 12 months of follow-up
Incomplete stent apposition.
Periodo de tiempo: After 12 months of follow-up
After 12 months of follow-up
Edge response in stented segment.
Periodo de tiempo: After 12 months of follow-up
After 12 months of follow-up
Stent expansion.
Periodo de tiempo: After 12 months of follow-up
After 12 months of follow-up
Evaluation of the OCT-technique in clinical use compared to IVUS.
Periodo de tiempo: After 12 months of follow-up
After 12 months of follow-up
Evaluation of the Resolute stents effect on neointima growth and apposition.
Periodo de tiempo: After 12 months of follow-up
After 12 months of follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Odense University Hospital

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2011

Finalización primaria (Actual)

1 de junio de 2014

Finalización del estudio (Actual)

1 de septiembre de 2014

Fechas de registro del estudio

Enviado por primera vez

28 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

29 de junio de 2011

Publicado por primera vez (Estimar)

30 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de septiembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2014

Última verificación

1 de septiembre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • OUH-OCTIVUS

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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