NCT01042730

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,054

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

6.3 years

First QC Date

January 5, 2010

Last Update Submit

May 14, 2021

Conditions

Coronary Artery Disease

Keywords

PitavastatinCoronary Artery DiseaseCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization)

    3-6 years

Secondary Outcomes (7)

  • Composite cardiovascular events

    3-6 years

  • Composite coronary heart disease events

    3-6 years

  • Composite cerebrovascular events

    3-6 years

  • Death events

    3-6 years

  • Heart disease events

    3-6 years

  • +2 more secondary outcomes

Study Arms (2)

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

Interventions

Pitavastatin 1 mg daily or 4 mg dailyDRUG

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.

Also known as: LIVALO Tablet
Pitavastatin 1 mg dailyPitavastatin 4 mg daily

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Juntendo University School of Medicine

Tokyo, Japan

Location

Related Publications (4)

  • 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.

    PMID: 39818975DERIVED

  • Iwata 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.

    PMID: 39130048DERIVED

  • Sakuma 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.

    PMID: 36372869DERIVED

  • Taguchi 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.

    PMID: 29735587DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular Diseases

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ryozo Nagai, MD, PhD

    Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

  • Masunori Matsuzaki, MD, PhD

    Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2016

Study Completion

November 1, 2017

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

JP(2)