UMIN-CTR Clinical Trial

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

Patients with stable coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Public Health Research Foundation

Institute

Department

Personal name

Organization

Public Health research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2009

Year

10

Month

27

Day

Last modified on

2018

Year

05

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003262