Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From July 2006 to January 2009, we randomized 78 patients with stable coronary artery disease (CAD) with LDL-C > 70 mg/dl, Angiographically documented CAD, stable angina, and age between 18 and 80 years. Patients were assigned randomly to two groups. The one group received Ezetimibe 10 mg/Simvastatin 20 mg the one other received Simvastatin 80 mg.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No wash-out period.

Reporting Groups

	Description
Simvastatin 80 mg	Patients were treated with simvastatin 80 mg for 6 weeks
Simvastatin 20mg/Ezetimibe 10 mg	Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks

Participant Flow:   Overall Study

	Simvastatin 80 mg	Simvastatin 20mg/Ezetimibe 10 mg
STARTED	38	40
COMPLETED	38	40
NOT COMPLETED	0	0

Reporting Groups

	Description
Simvastatin 80 mg	Patients were treated with simvastatin 80 mg for 6 weeks
Simvastatin 20mg/Ezetimibe 10 mg	Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks

Baseline Measures

	Simvastatin 80 mg	Simvastatin 20mg/Ezetimibe 10 mg	Total
Number of Participants   [units: participants]	38	40	78
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	35	37	72
>=65 years	3	3	6
Age   [units: years] Mean ± Standard Deviation	61.7  ± 10	64.5  ± 9	63.2  ± 10
Gender   [units: participants]
Female	18	15	33
Male	20	25	45
Region of Enrollment   [units: participants]
Brazil	38	40	78

1.  Primary:

C-reactive Protein   [ Time Frame: Change from baseline at 6 weeks ]

2.  Primary:

Oxidized Low-Density Lipoprotein Cholesterol   [ Time Frame: Change from baseline at 6 weeks ]

3.  Primary:

Platelet Function Analyzer [PFA]-100   [ Time Frame: Change from baseline at 6 weeks ]

4.  Primary:

Monocyte Chemoattractant Protein (MCP)-1   [ Time Frame: Change from baseline at 6 weeks ]

5.  Primary:

Soluble Intercellular Adhesion Molecule (sICAM)-1   [ Time Frame: Change from baseline at 6 weeks ]

6.  Primary:

Soluble CD40 Ligand   [ Time Frame: Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period. ]

7.  Primary:

Interleukin-6   [ Time Frame: Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period. ]

8.  Secondary:

LDL Cholesterol   [ Time Frame: Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period. ]

9.  Secondary:

Triglyceride   [ Time Frame: Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period. ]

10.  Secondary:

Endothelial Progenitor Cells   [ Time Frame: Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period. ]