Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

NCT01042730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13054

Last updated 2021-05-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pitavastatin 1 mg daily or 4 mg daily

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.

Sponsors & Collaborators

  • Tokyo University

    collaborator OTHER
  • Yamaguchi University Hospital

    collaborator OTHER
  • Tohoku University

    collaborator OTHER
  • Kyoto University

    collaborator OTHER
  • Kumamoto University

    collaborator OTHER
  • Juntendo University

    lead OTHER

Principal Investigators

  • Ryozo Nagai, MD, PhD · Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine

  • Masunori Matsuzaki, MD, PhD · Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2016-06-30
Completion
2017-11-30

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042730 on ClinicalTrials.gov