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

NCT ID: NCT01385631

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

ST-Segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Atorvastatin plus Placebo

50/100 patients are randomized to Atorvastatin 80 mg per day plus placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

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.

Interventions

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 Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ezetrol; Zarator; Ezetrol; Zarator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mikkel Hougaard

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikkel Hougaard, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Odense University Hospital

Locations

Department of Cardiology, Odense University Hospital

Odense C, , Denmark

Countries

Denmark

Other Identifiers

OUH-OCTIVUS

Identifier Type: -

Identifier Source: org_study_id