Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Anam Hospital
• Collaborator: Samjin Pharmaceutical Co., Ltd.
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Patients underwent percutaneous coronary intervention with drug-eluting stent;

Exclusion Criteria:

• Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates;

• Serum creatinine level > 2.0 mg/dL

• Serum aspartate transaminase > 3 times upper limit of normal

• Serum alanine transaminase > 3 times upper limit of normal

• Having anaphylactic reaction for Rosuvastatin;

• Having the other contraindications for Rosuvastatin;

• Having plan to be pregnant;

• Having life expectancy less than 1 year