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
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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