Trial Outcomes & Findings for Antiplatelet and Anti-inflammatory Effects of Statins and Ezetimibe (NCT NCT00474123)
NCT ID: NCT00474123
Last Updated: 2010-07-14
Results Overview
Serum was separated by centrifugation from the blood samples. For high-sensitivity C-Reactive Protein measurement, whole venous blood was collected in tubes without anticoagulant and centrifuged at room temperature. Serum C-Reactive Protein was assessed with a high-sensitivity, latex microparticle-enhanced immunoturbidimetric assay (Behring Nephelometer Analyzer System; Behring Diagnostics, Somerville, NJ).
COMPLETED
NA
78 participants
Change from baseline at 6 weeks
2010-07-14
Participant Flow
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.
No wash-out period.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiplatelet and Anti-inflammatory Effects of Statins and Ezetimibe
Baseline characteristics by cohort
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age Continuous
|
61.7 years
STANDARD_DEVIATION 10 • n=99 Participants
|
64.5 years
STANDARD_DEVIATION 9 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
78 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 6 weeksPopulation: per protocol
Serum was separated by centrifugation from the blood samples. For high-sensitivity C-Reactive Protein measurement, whole venous blood was collected in tubes without anticoagulant and centrifuged at room temperature. Serum C-Reactive Protein was assessed with a high-sensitivity, latex microparticle-enhanced immunoturbidimetric assay (Behring Nephelometer Analyzer System; Behring Diagnostics, Somerville, NJ).
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
C-reactive Protein
|
-16 Percentage
Interval -42.0 to 7.0
|
-11 Percentage
Interval -37.0 to 26.0
|
PRIMARY outcome
Timeframe: Change from baseline at 6 weeksPopulation: per protocol
Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting oxLDL (Mercodia, USA) were applied.
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Oxidized Low-Density Lipoprotein Cholesterol
|
-18 Percentage
Standard Deviation 47
|
-15 Percentage
Standard Deviation 33
|
PRIMARY outcome
Timeframe: Change from baseline at 6 weeksPopulation: per protocol
Samples were collected in 3.8% sodium citrate (buffered, pH 5.5, Vacutainer, Becton Dickinson, Plymouth, UK) for platelet function tests. Platelet function assays were processed within 2 hours of blood collection. The PFA-100 records the closure time (CT), witch means the time in seconds (s) from the start of the test until the platelet plug occludes the aperture.
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Platelet Function Analyzer [PFA]-100
|
27 Percentage
Standard Deviation 43
|
8 Percentage
Standard Deviation 33
|
PRIMARY outcome
Timeframe: Change from baseline at 6 weeksPopulation: per protocol
Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R\&D Systems, Europe, Abingdon, UK).
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Monocyte Chemoattractant Protein (MCP)-1
|
11 percentage
Standard Deviation 47
|
10 percentage
Standard Deviation 21
|
PRIMARY outcome
Timeframe: Change from baseline at 6 weeksPopulation: per protocol
serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R\&D Systems, Europe, Abingdon, UK)
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Soluble Intercellular Adhesion Molecule (sICAM)-1
|
10 percentage
Standard Deviation 14
|
10 percentage
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.A commercial ELISA assay detecting sCD40L (R\&D Systems, USA) was applied. Detection limits and intra-assay variability was respectively, as follows: sCD-40L 15.6 pg/mL (intra-assay variability not available).
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Soluble CD40 Ligand
|
6 percentage
Standard Deviation 43
|
6 percentage
Standard Deviation 34
|
PRIMARY outcome
Timeframe: Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.A commercial ELISA assay detecting IL-6 (Siemens, USA) was applied.
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Interleukin-6
|
0 percentage
Interval -22.0 to 24.0
|
0 percentage
Interval -14.0 to 0.0
|
SECONDARY outcome
Timeframe: Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
LDL Cholesterol
|
-28 percentage
Standard Deviation 30
|
-29 percentage
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Triglyceride
|
-4 percentage
Standard Deviation 32
|
-14 percentage
Standard Deviation 31
|
SECONDARY outcome
Timeframe: Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.Endothelial progenitor cells were evaluated by flow cytometry. Selected cells were positive for CD31, CD34 and VEGFR receptors.
Outcome measures
| Measure |
Simvastatin 80 mg
n=38 Participants
Patients were treated with simvastatin 80 mg for 6 weeks
|
Simvastatin 20mg/Ezetimibe 10 mg
n=40 Participants
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
|
|---|---|---|
|
Endothelial Progenitor Cells
|
0.4 percentage
Standard Deviation 1.7
|
0.1 percentage
Standard Deviation 2.1
|
Adverse Events
Simvastatin 80 mg
Simvastatin 20mg/Ezetimibe 10 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Comparison of Antiplatelet and Anti-inflammatory Effects of High Dose Statin Monotherapy Versus Mode
Heart Institute (InCor) Hospital of the Faculty of Medicine, University of São Paulo (HCFMUSP)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place