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Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation

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ClinicalTrials.gov Identifier: NCT00114504
Recruitment Status : Completed
First Posted : June 16, 2005
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Hisashi Kai, Kurume University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atherosclerosis
Intervention Drug: simvastatin
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Simvastatin Group Control Group
Hide Arm/Group Description Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
Period Title: Overall Study
Started 21 22
Completed 21 22
Not Completed 0 0
Arm/Group Title Simvastatin Group Control Group Total
Hide Arm/Group Description Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone Total of all reporting groups
Overall Number of Baseline Participants 21 22 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 43 participants
65  (9) 62  (6) 63  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
Female
8
  38.1%
8
  36.4%
16
  37.2%
Male
13
  61.9%
14
  63.6%
27
  62.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
Japanese 21 22 43
No Japanese 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 21 participants 22 participants 43 participants
21 22 43
1.Primary Outcome
Title Plaque Inflammation
Hide Description Change in plaque inflammation was assessed by changes in the plaque SUV.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group Control Group
Hide Arm/Group Description:
Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months
Overall Number of Participants Analyzed 21 22
Mean (Standard Deviation)
Unit of Measure: SUV
1.59  (0.22) 1.63  (0.12)
2.Secondary Outcome
Title Circulating Inflammation Marker
Hide Description Change in circulating hsCRP levels
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group Baseline Simvastatin Group at 3 Month Control Group Baseline Control Group at 3 Months
Hide Arm/Group Description:
Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline
Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline
Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
Overall Number of Participants Analyzed 21 21 22 22
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.09  (0.11) 0.06  (0.07) 0.11  (0.16) 0.07  (0.06)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Group Control Group
Hide Arm/Group Description Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
All-Cause Mortality
Simvastatin Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
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: Hisashi Kai
Organization: Kurume University
Phone: +81-942-31-7562
EMail: naikai@med.kurume-u.ac.jp
Layout table for additonal information
Responsible Party: Hisashi Kai, Kurume University
ClinicalTrials.gov Identifier: NCT00114504     History of Changes
Other Study ID Numbers: KurumeU-2416
First Submitted: June 15, 2005
First Posted: June 16, 2005
Results First Submitted: March 31, 2015
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015