NCT01008345

Brief Summary

Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4 coronary-artery-disease

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

September 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
Last Updated

November 6, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

November 4, 2009

Last Update Submit

November 5, 2009

Conditions

Coronary Artery DiseaseDiabetes

Outcome Measures

Primary Outcomes (1)

  • level of oxidized LDL cholesterol at end of study

    8 weeks of treatment

Secondary Outcomes (1)

  • small dense LDL level

    8 weeks of treatment

Study Arms (2)

ezetimibe

EXPERIMENTAL

will receive the active treatment with ezetimibe and statin

Drug: ezetimibe

placebo

PLACEBO COMPARATOR
Drug: ezetimibe

Interventions

ezetimibeDRUG

Patients will receive 10 mg/day of ezetimibe for 8 weeks

ezetimibeplacebo

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CAD or CAD equivalent

You may not qualify if:

  • Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage \>2 Creatinin clearance \< 30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de France Hospital

El Achrafiyé, Beyrouth, 0000, Lebanon

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • rabih azar, md

    Hotel Dieu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 6, 2009

Record last verified: 2009-11

Locations

LE(1)