NCT01042730

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13,054 (actual)
• Sponsor: Juntendo University · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2016-06-01
• Completion: 2017-11-01
• First posted: 2010-01-06
• Last updated: 2021-05-17

Locations

2 sites across 1 country: Japan