HyperlipidemiaPEACENCT00711919
Pitavastatin on Carotid Intima-media Thickness
A study testing Pitavastatin in people with Hyperlipidemia and Carotid Artery Diseases, run by Kyoto Prefectural University of Medicine at 18 sites in Japan.
Trial summary
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hyperlipidemia, Carotid Artery Diseases
- What is being tested?
- Pitavastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 18 sitesJapan
- Study dates
- Jul 2007to Dec 2009
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as having hyperlipidemia
- LDL-C at the time of enrollment is no less than 100
- Common carotid IMT is 1.1 mm and over
Who cannot join
- Received or planned to receive intervention on carotid arteries during the study period
- Overt liver dysfunction (ALT; 100 IU/L and over)
- Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
- Receiving Cyclosporin
- Hyperreactive to Pitavastatin
- During pregnancy or lactation
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Ayabe City Hospital
Ayabe, Kyoto, 623-0011
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, 620-8505
Shiga Hospital
Higashioumi, Shiga, 527-8505
Saiseikai Kyoto Hospital
Kōtari, Kyoto, 617-0814
Tanabe Central Hospital
Kyōtanabe, Kyoto, 610-0334
Kumihama Hospital
Kyōtango, Kyoto, 629-3400
Takeda Hospital
Kyoto, Kyoto, 600-8558
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Kyoto First Red Cross Hospital
Kyoto, Kyoto, 605-0981
Maizuru Medical Center
Maizuru, Kyoto, 625-8502
Maizuru Kyosai Hospital
Maizuru, Kyoto, 625-8585
Nantan General Hospital
Nantan, Kyoto, 629-0197
Meiji University of Integrative Medicine Hospital
Nantan, Kyoto, 629-0392
Omihachiman Community Medical Center
Ōmihachiman, Shiga, 523-0082
Saiseikai Shigaken Hospital
Rittou, Shiga, 520-3046
Gakken Toshi Hospital
Sugai, Kyoto, 619-0238
Uji Hospital
Uji, Kyoto, 611-0011
Kyoto Prefectural Yosanoumi Hospital
Yotsutsuji, Kyoto, 629-2261
About this study
Official title: Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
- Conditions
- Hyperlipidemia, Carotid Artery Diseases
- Being tested
- Pitavastatin
- Medical subject headings
- Hyperlipidemias, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
comparison of different target levels of lipid lowering using Pitavastatin
Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
PitavastatinDrug
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. Receives: Drug: Pitavastatin |
| 2 | Active comparator | Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute changes in carotid intima-media thickness from baseline to final visit
Measured: 12 months
Secondary outcomes (6)
relative change in carotid intima-media thickness
Measured: 12 months
change in LDL-C, HDL-C, TG and RLP-C
Measured: 12 months
change in hs-CRP and IL-6
Measured: 12 months
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
Measured: 12 months
sudden death
Measured: 12 months
side effects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto Prefectural University of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Hiroaki Matsubara, MD, PhD, Study chair, Kyoto Prefectural University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711919
- Sponsor's protocol ID
- C-255
- Other IDs
- UMIN000001229
- Acronym
- PEACE
- Status last verified
- Sep 2009
- First submitted
- 7 Jul 2008
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PubMed 37565307Ikeda K, Takahashi T, Yamada H, Matsui K, Sawada T, Nakamura T, Matsubara H; (for the PEACE Investigators). Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study). Eur J Prev Cardiol. 2013 Dec;20(6):1069-79. doi: 10.1177/2047487312451539. Epub 2012 Jun 11.
PubMed 22689416
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
- ClinicalTrials.gov ID
- NCT00711919
- Acronym / sponsor ID
- PEACE / C-255
- Conditions
- Hyperlipidemia, Carotid Artery Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kyoto Prefectural University of MedicineUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (estimated)
- First posted
- 9 Jul 2008 (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.
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PitavastatinSubjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. |
| 2 | Active comparator | Drug: PitavastatinSubjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as having hyperlipidemia
- LDL-C at the time of enrollment is no less than 100
- Common carotid IMT is 1.1 mm and over
Key exclusion criteria (6 listed)
- Received or planned to receive intervention on carotid arteries during the study period
- Overt liver dysfunction (ALT; 100 IU/L and over)
- Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
- Receiving Cyclosporin
- Hyperreactive to Pitavastatin
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 |
|---|---|---|
| Pitavastatincomparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. | Drug | 1 |
| PitavastatinSubjects are receiving Pitavastatin, starting at 4 mg, for 12 months. | Drug | 2 |
Primary outcome
absolute changes in carotid intima-media thickness from baseline to final visit
Time frame: 12 months
6 secondary outcomes
relative change in carotid intima-media thickness
Time frame: 12 months
change in LDL-C, HDL-C, TG and RLP-C
Time frame: 12 months
change in hs-CRP and IL-6
Time frame: 12 months
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
Time frame: 12 months
sudden death
Time frame: 12 months
side effects
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2009.
- Derived from this study: PubMed 37565307Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
- Derived from this study: PubMed 22689416Ikeda K, Takahashi T, Yamada H, Matsui K, Sawada T, Nakamura T, Matsubara H; (for the PEACE Investigators). Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study). Eur J Prev Cardiol. 2013 Dec;20(6):1069-79. doi: 10.1177/2047487312451539. Epub 2012 Jun 11.
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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.
Hiroaki Matsubara, MD, PhD study chair
Kyoto Prefectural University of Medicine
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pitavastatin in people with Hyperlipidemia and Carotid Artery Diseases, run by Kyoto Prefectural University of Medicine at 18 sites 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 3 inclusion and 6 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 10 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute changes in carotid intima-media thickness from baseline to final visit (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711919, which also lists 2 linked publications.
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 10 Sep 2009.