Trial Outcomes & Findings for Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation (NCT NCT00114504)

NCT ID: NCT00114504

Last Updated: 2015-06-01

Results Overview

Change in plaque inflammation was assessed by changes in the plaque SUV.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2015-06-01

Participant Flow

Participant milestones

Measure	Simvastatin Group Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy	Control Group Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
Overall Study STARTED	21	22
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Simvastatin Group n=21 Participants Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy	Control Group n=22 Participants Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone	Total n=43 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 9 • n=5 Participants	62 years STANDARD_DEVIATION 6 • n=7 Participants	63 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Race/Ethnicity, Customized No Japanese	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment Japan	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Change in plaque inflammation was assessed by changes in the plaque SUV.

Outcome measures

Measure	Simvastatin Group n=21 Participants Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months	Control Group n=22 Participants Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months	Control Group Baseline Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline	Control Group at 3 Months Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
Plaque Inflammation	1.59 SUV Standard Deviation 0.22	1.63 SUV Standard Deviation 0.12	—	—

SECONDARY outcome

Timeframe: Baseline, 3 months

Change in circulating hsCRP levels

Outcome measures

Measure	Simvastatin Group n=21 Participants Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months	Control Group n=21 Participants Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months	Control Group Baseline n=22 Participants Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline	Control Group at 3 Months n=22 Participants Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
Circulating Inflammation Marker	0.09 mg/dL Standard Deviation 0.11	0.06 mg/dL Standard Deviation 0.07	0.11 mg/dL Standard Deviation 0.16	0.07 mg/dL Standard Deviation 0.06

Adverse Events

Simvastatin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hisashi Kai

Kurume University

Phone: +81-942-31-7562

Email: naikai@med.kurume-u.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place