AtherosclerosisPhase 4NCT00920101
Anti-inflammatory Effect of Atorvastatin in Atherosclerotic Plaques Assessed by FDG-PET Imaging
A Phase 4 study testing Atorvastatin and Lifestyle counseling in people with Atherosclerosis and Inflammation, run by National Defense Medical College, Japan at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis, Inflammation
- What is being tested?
- Atorvastatin and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2009to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with accumulation of FDG-PET in carotid artery or aorta
Who cannot join
- LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl
- subjects currently taking HMG CoA-reductase (Statins) or fibrates
- symptomatic coronary artery diseases
- symptomatic cerebrovascular diseases
- subjects suffered from myocardial infarction or stroke within 6 months
- subjects underwent percutaneous vascular interventions or vascular operations within 6 months
Show all 10Show fewer
- diabetic patients with poor glycemic control (HbA1c>8.5)
- hypertensive patients with poor blood pressure control
- subjects with neoplasms
- subjects with systemic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
National Defense medical College
Tokotozawa, Saitama, 359-8513
Makoto Ayaori, MD, 81429951617, ayaori@ndmc.ac.jp
About this study
Official title: Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging
The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.
- Conditions
- Atherosclerosis, Inflammation
- Being tested
- Atorvastatin, Lifestyle counseling
- Keywords
- atherosclerotic plaques, hypercholesterolemia, HMG-CoA reductase inhibitor, statin, lipid-lowering therapy
- Medical subject headings
- Atherosclerosis, Inflammation, Plaque, Atherosclerotic, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less.
Lifestyle counselingBehavioural
Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
| Lifestyle counseling | Placebo comparator | Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques
Measured: Baseline and 3 months after intervention
Secondary outcomes (5)
Flow-mediated vasodilation of brachial artery determined by ultrasonography
Measured: Baseline and 3 months after intervention
Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1
Measured: Baseline and 3 months after intervention
Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine
Measured: Baseline and 3 months after intervention
Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography
Measured: Baseline and 3 months after intervention
Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides
Measured: Baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical College, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Ayaori, National Defense Medical College, Japan
- Investigators
- Katsunori Ikewaki, Principal investigator, National Defense Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920101
- Sponsor's protocol ID
- NDMC570
- Status last verified
- Mar 2013
- First submitted
- 12 Jun 2009
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging
- ClinicalTrials.gov ID
- NCT00920101
- Acronym / sponsor ID
- NDMC570
- Conditions
- Atherosclerosis, Inflammation
- Keywords
- atherosclerotic plaques, hypercholesterolemia, HMG-CoA reductase inhibitor, statin, lipid-lowering therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Defense Medical College, JapanUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin |
| Lifestyle counseling | Placebo comparator | Behavioral: Lifestyle counselingSubjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with accumulation of FDG-PET in carotid artery or aorta
Key exclusion criteria (10 listed)
- LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl
- subjects currently taking HMG CoA-reductase (Statins) or fibrates
- symptomatic coronary artery diseases
- symptomatic cerebrovascular diseases
- subjects suffered from myocardial infarction or stroke within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: LipitorSubjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less. | Drug | Atorvastatin |
| Lifestyle counselingSubjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. | Behavioural | Lifestyle counseling |
Primary outcome
Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques
Time frame: Baseline and 3 months after intervention
5 secondary outcomes
Flow-mediated vasodilation of brachial artery determined by ultrasonography
Time frame: Baseline and 3 months after intervention
Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1
Time frame: Baseline and 3 months after intervention
Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine
Time frame: Baseline and 3 months after intervention
Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography
Time frame: Baseline and 3 months after intervention
Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides
Time frame: Baseline and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katsunori Ikewaki principal investigator
National Defense Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Lifestyle counseling in people with Atherosclerosis and Inflammation, run by National Defense Medical College, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Makoto Ayaori, MD (81429951617, ayaori@ndmc.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.