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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mikkel Hougaard, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01385631
First received: June 28, 2011
Last updated: September 1, 2014
Last verified: September 2014

June 28, 2011
September 1, 2014
June 2011
June 2014   (final data collection date for primary outcome measure)
Plaque volume and composition in a non-significant coronary plaque [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
Plaque volume assessed by intravascular ultrasound and Optical Coherence Tomography
Same as current
Complete list of historical versions of study NCT01385631 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Change in percent of the plaque volume in the native coronary vessel with a non-significant stenosis. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Change in percent of the plaque burden in a native coronary vessel with a non-significant lesion. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Incomplete stent apposition. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Edge response in stented segment. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Stent expansion. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Evaluation of the OCT-technique in clinical use compared to IVUS. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
  • Evaluation of the Resolute stents effect on neointima growth and apposition. [ Time Frame: After 12 months of follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
ST-Segment Elevation Myocardial Infarction
  • Drug: 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.
    Other Names:
    • Ezetrol
    • Zarator
  • Drug: 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.
    Other Names:
    • Ezetrol
    • Zarator
  • Placebo Comparator: Atorvastatin plus Placebo
    50/100 patients are randomized to Atorvastatin 80 mg per day plus placebo.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
September 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 81 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01385631
OUH-OCTIVUS
Yes
Mikkel Hougaard, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Mikkel Hougaard, MD Department of Cardiology, Odense University Hospital
Odense University Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP