Coronary Artery DiseaseNCT01042730
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
A study testing Pitavastatin 1 mg daily or 4 mg daily in people with Coronary Artery Disease, run by Juntendo University at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Pitavastatin 1 mg daily or 4 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,054 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2010to Nov 2017
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration)
- Coronary artery disease patients meeting one of the following events
- History of Acute Coronary Syndrome (AMI or Unstable angina)
- History of revascularization (PCI or CABG)
- Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification
- Hypercholesterolemia patients meeting one of following criteria
Show all 11Show fewer
- LDL-C is 140 mg/dL or over
- LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
- Patents receiving cholesterol lowering drugs
- Age (≧20 <80 year-old)
- Patients given written informed consent.
Who cannot join
- Patients planning revascularization
- Malignant tumor in active phase
- Patients who meet contraindication of LIVALO tablet below
- Patients who have hypersensitivity to LIVALO tablet
- Patients who have severe liver dysfunction or biliary atresia
- Patients who are being treated with cyclosporine
Show all 20Show fewer
- Pregnant women, women suspected of being pregnant, or lactating women
- Patients who have heart failure NYHA III or greater
- Patients undergoing dialysis
- Patients with familial hypercholesterolemia
- Patients registered in the other clinical trials
- Patients taking prohibited drugs
- Patients who are ineligible in the opinion of the investigator
- LDL-C is 120mg/dL or over after Run-in period
- Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months
- Patients who have been undergone PCI or CABG within 3 months
- Compliance is less than 50% in Run-in period
- Patients who met primary endpoint in Run-in period.
- Patients who met adverse events in Run-in period and judged as ineligible in the opinion of the investigator
- Patients who are ineligible in the opinion of the investigator
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Kyoto University Hospital
Kyoto, 606-8507
Juntendo University School of Medicine
Tokyo
About this study
The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.
Read the detailed description
It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.
- Conditions
- Coronary Artery Disease
- Being tested
- Pitavastatin 1 mg daily or 4 mg daily
- Keywords
- Pitavastatin, Coronary Artery Disease, Cardiovascular Disease
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin 1 mg daily or 4 mg dailyDrug
Also called LIVALO Tablet
Patients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 1 mg daily | Active comparator | Not described Receives: Drug: Pitavastatin 1 mg daily or 4 mg daily |
| Pitavastatin 4 mg daily | Active comparator | Not described Receives: Drug: Pitavastatin 1 mg daily or 4 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization)
Measured: 3-6 years
Secondary outcomes (7)
Composite cardiovascular events
Measured: 3-6 years
Composite coronary heart disease events
Measured: 3-6 years
Composite cerebrovascular events
Measured: 3-6 years
Death events
Measured: 3-6 years
Heart disease events
Measured: 3-6 years
Cerebrovascular events
Measured: 3-6 years
The other events
Measured: 3-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juntendo University
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo University, Yamaguchi University Hospital, Tohoku University, Kyoto University, Kumamoto University
- Responsible party
- Sponsor
- Investigators
- Ryozo Nagai, MD, PhD, Principal investigator, Department of Cardiovascular Medicine, University of Tokyo Graduate School of MedicineMasunori Matsuzaki, MD, PhD, Principal investigator, Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042730
- Sponsor's protocol ID
- CSP-LD-09
- Status last verified
- May 2021
- First submitted
- 5 Jan 2010
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoshiki Y, Ozaki Y, Abe M, Ismail TF, Takahashi H, Akao M, Kawai H, Muramatsu T, Harada M, Ohta M, Hashimoto Y, Shiki Y, Koshikawa M, Miyajima K, Takatsu H, Niwa Y, Kawashima N, Ozaki R, Tsuboi N, Iimuro S, Iwata H, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Ogawa H, Daida H, Shimokawa H, Izawa H, Kimura T, Nagai R; REAL-CAD investigators. Influence of Worsening Renal Function and Baseline Chronic Kidney Disease on Clinical Outcomes in Patients With Chronic Coronary Syndromes: Insights From the REAL-CAD Study. J Am Heart Assoc. 2025 Jan 21;14(2):e034627. doi: 10.1161/JAHA.124.034627. Epub 2025 Jan 17.
PubMed 39818975Iwata H, Miyauchi K, Naito R, Iimuro S, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Saito Y, Ogawa H, Shimokawa H, Daida H, Kimura T, Nagai R. Significance of Persistent Inflammation in Patients With Chronic Coronary Syndrome: Insights From the REAL-CAD Study. JACC Adv. 2024 Jun 5;3(7):100996. doi: 10.1016/j.jacadv.2024.100996. eCollection 2024 Jul.
PubMed 39130048Sakuma M, Iimuro S, Shinozaki T, Kimura T, Nakagawa Y, Ozaki Y, Iwata H, Miyauchi K, Daida H, Suwa S, Sakuma I, Nishihata Y, Saito Y, Ogawa H, Matsuzaki M, Ohashi Y, Taguchi I, Toyoda S, Inoue T, Nagai R. Optimal target of LDL cholesterol level for statin treatment: challenges to monotonic relationship with cardiovascular events. BMC Med. 2022 Nov 14;20(1):441. doi: 10.1186/s12916-022-02633-5.
PubMed 36372869Taguchi I, Iimuro S, Iwata H, Takashima H, Abe M, Amiya E, Ogawa T, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Yamazaki T, Ito H, Otsuji Y, Kimura K, Takahashi J, Hirayama A, Yokoi H, Kitagawa K, Urabe T, Okada Y, Terayama Y, Toyoda K, Nagao T, Matsumoto M, Ohashi Y, Kaneko T, Fujita R, Ohtsu H, Ogawa H, Daida H, Shimokawa H, Saito Y, Kimura T, Inoue T, Matsuzaki M, Nagai R. High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD): A Randomized Superiority Trial. Circulation. 2018 May 8;137(19):1997-2009. doi: 10.1161/CIRCULATIONAHA.117.032615.
PubMed 29735587
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
- ClinicalTrials.gov ID
- NCT01042730
- Acronym / sponsor ID
- CSP-LD-09
- Conditions
- Coronary Artery Disease
- Keywords
- Pitavastatin, Coronary Artery Disease, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,054 participants (actual)
- Lead sponsor
- Juntendo UniversityUniversity, hospital or other
- Collaborators
- Tokyo University, Yamaguchi University Hospital, Tohoku University, Kyoto University, Kumamoto University
- Study start
- Feb 2010 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 Jan 2010 (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 evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.
Detailed description
It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 1 mg daily | Active comparator | Drug: Pitavastatin 1 mg daily or 4 mg daily |
| Pitavastatin 4 mg daily | Active comparator | Drug: Pitavastatin 1 mg daily or 4 mg daily |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration)
- Coronary artery disease patients meeting one of the following events
- Hypercholesterolemia patients meeting one of following criteria
- Age (≧20 <80 year-old)
- Patients given written informed consent.
Key exclusion criteria (20 listed)
- Patients planning revascularization
- Malignant tumor in active phase
- Patients who meet contraindication of LIVALO tablet below
- Patients who have heart failure NYHA III or greater
- Patients undergoing dialysis
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 |
|---|---|---|
| Pitavastatin 1 mg daily or 4 mg dailyAlso: LIVALO TabletPatients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day. | Drug | Pitavastatin 1 mg daily, Pitavastatin 4 mg daily |
Primary outcome
Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization)
Time frame: 3-6 years
7 secondary outcomes
Composite cardiovascular events
Time frame: 3-6 years
Composite coronary heart disease events
Time frame: 3-6 years
Composite cerebrovascular events
Time frame: 3-6 years
Death events
Time frame: 3-6 years
Heart disease events
Time frame: 3-6 years
Cerebrovascular events
Time frame: 3-6 years
The other events
Time frame: 3-6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 39818975Yoshiki Y, Ozaki Y, Abe M, Ismail TF, Takahashi H, Akao M, Kawai H, Muramatsu T, Harada M, Ohta M, Hashimoto Y, Shiki Y, Koshikawa M, Miyajima K, Takatsu H, Niwa Y, Kawashima N, Ozaki R, Tsuboi N, Iimuro S, Iwata H, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Ogawa H, Daida H, Shimokawa H, Izawa H, Kimura T, Nagai R; REAL-CAD investigators. Influence of Worsening Renal Function and Baseline Chronic Kidney Disease on Clinical Outcomes in Patients With Chronic Coronary Syndromes: Insights From the REAL-CAD Study. J Am Heart Assoc. 2025 Jan 21;14(2):e034627. doi: 10.1161/JAHA.124.034627. Epub 2025 Jan 17.
- Derived from this study: PubMed 39130048Iwata H, Miyauchi K, Naito R, Iimuro S, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Saito Y, Ogawa H, Shimokawa H, Daida H, Kimura T, Nagai R. Significance of Persistent Inflammation in Patients With Chronic Coronary Syndrome: Insights From the REAL-CAD Study. JACC Adv. 2024 Jun 5;3(7):100996. doi: 10.1016/j.jacadv.2024.100996. eCollection 2024 Jul.
- Derived from this study: PubMed 36372869Sakuma M, Iimuro S, Shinozaki T, Kimura T, Nakagawa Y, Ozaki Y, Iwata H, Miyauchi K, Daida H, Suwa S, Sakuma I, Nishihata Y, Saito Y, Ogawa H, Matsuzaki M, Ohashi Y, Taguchi I, Toyoda S, Inoue T, Nagai R. Optimal target of LDL cholesterol level for statin treatment: challenges to monotonic relationship with cardiovascular events. BMC Med. 2022 Nov 14;20(1):441. doi: 10.1186/s12916-022-02633-5.
- Derived from this study: PubMed 29735587Taguchi I, Iimuro S, Iwata H, Takashima H, Abe M, Amiya E, Ogawa T, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Yamazaki T, Ito H, Otsuji Y, Kimura K, Takahashi J, Hirayama A, Yokoi H, Kitagawa K, Urabe T, Okada Y, Terayama Y, Toyoda K, Nagao T, Matsumoto M, Ohashi Y, Kaneko T, Fujita R, Ohtsu H, Ogawa H, Daida H, Shimokawa H, Saito Y, Kimura T, Inoue T, Matsuzaki M, Nagai R. High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD): A Randomized Superiority Trial. Circulation. 2018 May 8;137(19):1997-2009. doi: 10.1161/CIRCULATIONAHA.117.032615.
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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.
Ryozo Nagai, MD, PhD principal investigator
Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine
Masunori Matsuzaki, MD, PhD principal investigator
Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pitavastatin 1 mg daily or 4 mg daily in people with Coronary Artery Disease, run by Juntendo University at 2 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 11 inclusion and 20 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: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization) (time frame: 3-6 years). 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 NCT01042730, which also lists 4 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 17 May 2021.