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Antiplatelet and Anti-inflammatory Effects of Statins and Ezetimibe

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ClinicalTrials.gov Identifier: NCT00474123
Recruitment Status : Completed
First Posted : May 16, 2007
Results First Posted : July 14, 2010
Last Update Posted : July 14, 2010
Sponsor:
Information provided by:
University of Sao Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stable Angina
Interventions Drug: Simvastatin 80 mg/day for 6 weeks
Drug: Ezetimibe 10 mg / Simvastatin 20 mg
Enrollment 78
Recruitment Details 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 No wash-out period.
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description Patients were treated with simvastatin 80 mg for 6 weeks Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Period Title: Overall Study
Started 38 40
Completed 38 40
Not Completed 0 0
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg Total
Hide Arm/Group Description Patients were treated with simvastatin 80 mg for 6 weeks Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
  92.1%
37
  92.5%
72
  92.3%
>=65 years
3
   7.9%
3
   7.5%
6
   7.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 40 participants 78 participants
61.7  (10) 64.5  (9) 63.2  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Female
18
  47.4%
15
  37.5%
33
  42.3%
Male
20
  52.6%
25
  62.5%
45
  57.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 38 participants 40 participants 78 participants
38 40 78
1.Primary Outcome
Title C-reactive Protein
Hide Description 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).
Time Frame Change from baseline at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Median (Inter-Quartile Range)
Unit of Measure: Percentage
-16
(-42 to 7)
-11
(-37 to 26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin 80 mg, Simvastatin 20mg/Ezetimibe 10 mg
Comments The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Oxidized Low-Density Lipoprotein Cholesterol
Hide Description 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.
Time Frame Change from baseline at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: Percentage
-18  (47) -15  (33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin 80 mg, Simvastatin 20mg/Ezetimibe 10 mg
Comments The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Platelet Function Analyzer [PFA]-100
Hide Description 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.
Time Frame Change from baseline at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: Percentage
27  (43) 8  (33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin 80 mg, Simvastatin 20mg/Ezetimibe 10 mg
Comments The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Monocyte Chemoattractant Protein (MCP)-1
Hide Description 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).
Time Frame Change from baseline at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: percentage
11  (47) 10  (21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin 80 mg, Simvastatin 20mg/Ezetimibe 10 mg
Comments The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Soluble Intercellular Adhesion Molecule (sICAM)-1
Hide Description 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)
Time Frame Change from baseline at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: percentage
10  (14) 10  (16)
6.Primary Outcome
Title Soluble CD40 Ligand
Hide Description 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).
Time Frame Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: percentage
6  (43) 6  (34)
7.Primary Outcome
Title Interleukin-6
Hide Description A commercial ELISA assay detecting IL-6 (Siemens, USA) was applied.
Time Frame Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Median (Inter-Quartile Range)
Unit of Measure: percentage
0
(-22 to 24)
0
(-14 to 0)
8.Secondary Outcome
Title LDL Cholesterol
Hide Description [Not Specified]
Time Frame Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: percentage
-28  (30) -29  (13)
9.Secondary Outcome
Title Triglyceride
Hide Description [Not Specified]
Time Frame Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: percentage
-4  (32) -14  (31)
10.Secondary Outcome
Title Endothelial Progenitor Cells
Hide Description Endothelial progenitor cells were evaluated by flow cytometry. Selected cells were positive for CD31, CD34 and VEGFR receptors.
Time Frame Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description:
Patients were treated with simvastatin 80 mg for 6 weeks
Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: percentage
0.4  (1.7) 0.1  (2.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Hide Arm/Group Description Patients were treated with simvastatin 80 mg for 6 weeks Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
All-Cause Mortality
Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin 80 mg Simvastatin 20mg/Ezetimibe 10 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/40 (0.00%) 
Adverse Events were assessed, but none were observed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Comparison of Antiplatelet and Anti-inflammatory Effects of High Dose Statin Monotherapy Versus Mode
Organization: Heart Institute (InCor) Hospital of the Faculty of Medicine, University of São Paulo (HCFMUSP)
Phone: 55-11-30695058
EMail: eduardopesaro@hotmail.com
Layout table for additonal information
Responsible Party: São Paulo Research Foundation (FAPESP)
ClinicalTrials.gov Identifier: NCT00474123    
Other Study ID Numbers: 893/05
First Submitted: May 15, 2007
First Posted: May 16, 2007
Results First Submitted: January 8, 2010
Results First Posted: July 14, 2010
Last Update Posted: July 14, 2010