NCT01385631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

June 28, 2011

Last Update Submit

September 1, 2014

Conditions

ST-Segment Elevation Myocardial Infarction

Keywords

ST-Segment Elevation Myocardial InfarctionIntravascular ultrasoundIVUSOptical coherence tomographyOCTEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsAtorvastatinRandomized trialHypolipidemic AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Outcome Measures

Primary Outcomes (1)

  • Plaque volume and composition in a non-significant coronary plaque

    Plaque volume assessed by intravascular ultrasound and Optical Coherence Tomography

    After 12 months of follow-up

Secondary Outcomes (11)

  • 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.

    After 12 months of follow-up

  • Change in percent of the plaque volume in the native coronary vessel with a non-significant stenosis.

    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.

    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.

    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.

    After 12 months of follow-up

  • +6 more secondary outcomes

Study Arms (2)

Atorvastatin plus Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Atorvastatin plus Ezetimibe

EXPERIMENTAL

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.

Drug: Ezetimibe

Interventions

EzetimibeDRUG

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.

Also known as: Ezetrol, Zarator
Atorvastatin plus Ezetimibe
PlaceboDRUG

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.

Also known as: Ezetrol, Zarator
Atorvastatin plus Placebo

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Odense University Hospital

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mikkel Hougaard, MD

    Department of Cardiology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

DK(1)