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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002680
Receipt No. R000003262
Scientific Title Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease(REAL-CAD)
Date of disclosure of the study information 2009/10/27
Last modified on 2018/05/15

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Basic information
Public title Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease(REAL-CAD)
Acronym Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease(REAL-CAD)
Scientific Title Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease(REAL-CAD)
Scientific Title:Acronym Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease(REAL-CAD)
Region
Japan Asia(except Japan)

Condition
Condition Patients with stable coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the prevention from cardiovascular disease by standard cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of one of following events
1. Cardiovascular death
2. Non-fatal Myocardial Infarction
3. Non-fatal Cerebral Infarction
4.Unstable angina requiring urgent hospitalizations
Key secondary outcomes 1.Composite cardiovascular events
Occurrence of one of following events
Cardiovascular death, Non-fatal MI, Non-fatal CI, Unstable angina requiring hospitalizations, Ischemia-driven coronary revascularization except target lesion revascularization (TLR)
2. Composite coronary heart disease events
Occurrence of one of following events
Coronary heart disease (CHD) death, Non-fatal MI, Unstable angina requiring urgent hospitalizations, Ischemia-driven coronary revascularization except TLR.
3.Composite cerebrovascular events
Occurrence of one of following events
Fatal and Non-fatal stroke, Transient ischemic attack (TIA) requiring hospitalizations.
4.Death events
Occurrence of each following events
All-cause mortality
Cardiovascular death
Cardiac death
CHD death
5.Heart disease events
Occurrence of each following events
Fatal and Non-fatal MI
Non-procedure related MI
Procedure related MI
Unstable angina requiring urgent hospitalizations
Resuscitated cardiac arrest
Hospitalization for heart failure
PCI or CABG
(1)All events of PCI or CABG
(a)TLR
(b)non-TLR
(2)Ischemia-driven PCI or CABG
(a)TLR
(b)non-TLR
6. Cerebrovascular events
Occurrence of each following events
Fatal and Non-fatal stroke
Fatal and Non-fatal CI
(1) Non-procedure related CI
(2) Procedure related CI
Fatal and Non-fatal cerebral hemorrhage
Hospitalization for TIA
7. The other events
Occurrence of each following events
Operation for or rupture of aortic aneurysm
Revascularization for peripheral arterial disease (PAD)
Carotid artery stenting (CAS) or carotid endarterectomy (CEA)
Aortic dissection
Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE)
New occurrence of malignant tumor
Operation for aortic stenosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin 4 mg daily
Interventions/Control_2 Pitavastatin 1 mg daily
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who met following all criteria were entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration)
(1) Coronary artery disease patients
Meeting one of following events
1) History of Acute Coronary Syndrome (AMI or Unstable angina)
2) History of revascularization (PCI or CABG)
3) Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification
(2) Hypercholesterolemia patients
Meeting one of following criteria
1) LDL-C is 140 mg/dL or over
2) LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
3) Patents receiving cholesterol lowering drugs
(3) Age (20<= <80 year-old)
(4) Patients given written informed consent.
Key exclusion criteria Exclusion Criteria(1) (Pre-Run-in period)
1. Patients planed revascularization
2. Malignant tumor in active phase
3. Patients who meet contraindication of LIVALO tablet below
1) Patients who have hypersensitivity to LIVALO tablet
2) Patients who have severe liver dysfunction or biliary atresia.
3)Patients who are being treated with cyclosporine
4) Pregnant women, women suspected of being pregnant, or lactating women
4. Patients who have heart failure NYHA III or greater
5. Patients undergoing dialysis
6. Patients with familial hypercholesterolemia
7. Patients registered in the other clinical trials
8. Patients with prohibited drugs
9. Patients who are ineligible in the opinion of the investigator

Exclusion Criteria(2) (Post-Run-in period)
1. LDL-C is 120mg/dL or over after Run-in period
2. Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months
3. Patients who have been undergone PCI or CABG within 3 months
4. Compliance is less than 50% in Run-in period
5. Patients who met primary endpoint or adverse events in Run-in period and judged as ineligible in the opinion of the investigator
6. Patients who are ineligible in the opinion of the investigator
Target sample size 12600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryozou Nagai/ Masunori Matsuzaki
Organization Jichi Medicai University / Yamaguchi University Graduate School of Medicine
Division name President / Division of Cardiology, Department of Medicine and Clinical Science
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0498 .
TEL 03-5800-6526.0836-22-2248
Email real-cad@csp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruhiko Miyazaki
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Clinical Research
Zip code
Address 1-1-7 3F Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051
TEL 03-5287-2633
Homepage URL http://csp.or.jp/ld/real-cad/
Email csp-ld@csp.or.jp

Sponsor
Institute Public Health Research Foundation
Institute
Department

Funding Source
Organization Public Health research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://circ.ahajournals.org/content/137/19/1997.full?ijkey=rYGV7lJAO7FaYSB&keytype=ref
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 12 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 23 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 03 Month 10 Day
Date analysis concluded
2017 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 27 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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