N/A
N=78
Antiplatelet and Anti-inflammatory Effects of Statins and Ezetimibe
Stable Angina
Bottom Line
View on ClinicalTrials.gov: NCT00474123 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: C-reactive Protein — -16; -11 Percentage — p=0.3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Simvastatin 80 mg/day for 6 weeks (Drug); Ezetimibe 10 mg / Simvastatin 20 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-reactive Protein |
-16; -11 | 0.3 |
| PRIMARY Oxidized Low-Density Lipoprotein Cholesterol |
-18; -15 | 0.65 |
| PRIMARY Platelet Function Analyzer [PFA]-100 |
27; 8 | 0.02 sig |
| PRIMARY Monocyte Chemoattractant Protein (MCP)-1 |
11; 10 | 0.85 |
| PRIMARY Soluble Intercellular Adhesion Molecule (sICAM)-1 |
10; 10 | — |
| PRIMARY Soluble CD40 Ligand |
6; 6 | — |
| PRIMARY Interleukin-6 |
0; 0 | — |
| SECONDARY LDL Cholesterol |
-28; -29 | — |
| SECONDARY Triglyceride |
-4; -14 | — |
| SECONDARY Endothelial Progenitor Cells |
0.4; 0.1 | — |
Summary
Among patients with stable coronary artery disease (CAD), it is not clear if the pleiotropic effects of cholesterol reduction differ between high-dose simvastatin alone and combined ezetimibe/simvastatin.
The investigators sought to compare the anti-inflammatory and anti-platelet effects of ezetimibe 10 mg / simvastatin 20 mg (E10/S20) to simvastatin 80 mg (S80).
Eligibility Criteria
Inclusion Criteria
- Stable angina
- Low-density lipoprotein (LDL) cholesterol 70-160 mg/dl
Exclusion Criteria
- Renal failure
- Age>80
- Simvastatin current treatment>20mg
- Hepatic disease
- Inflammatory diseases
Data sourced from ClinicalTrials.gov (NCT00474123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.