Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI (ROSUVA-30)

August 4, 2016 updated by: Hyung Joon Joo, Korea University Anam Hospital

Effectiveness and Safety of Low-dose vs. High-dose Rosuvastatin on Long-term Cardiovascular Events in Korean Patients After Percutaneous Coronary Intervention: 30-month, Prospective, Single-center, Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

With the development of the newer generation drug-eluting stents, percutaneous coronary intervention (PCI) has been a feasible treatment for patient with coronary artery disease. However, stent failures including in-stent restenosis and stent thrombosis have been still problematic. Moreover, neoatherosclerosis, which is the atherosclerotic process developed in the neointima within the implanted stent, has been reported to be associated with neoatherosclerotic plaque rupture and contribute to the development of acute coronary syndrome in patients after drug-eluting stent (DES) implantation.

In this perspective, recent AHA/ACC and ESC guidelines recommend the high-dose(intensity) statin therapy for patients performed PCI. However, the efficacy of the high-dose(intensity) statin therapy on cardiovascular outcomes is still controversial. Several meta-analysis failed to show the benefit of the high-dose(intensity) statin therapy to reduce the mortality. Moreover, clear evidence for the benefits of such high-dose(intensity) statin therapy has no yet been demonstrated in East Asian patients.

This trial was 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 PCI in the era of the newer generation DES era.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin 5mg
Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention
Drug: Rosuvastatin 5mg
Rosuvastatin 5mg tablet, q.d., for 30 months
Other Names:
  • Low dose group
Active Comparator: Rosuvastatin 20mg
Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention
Drug: Rosuvastatin 20mg
Rosuvastatin 5mg tablet, q.d., for 30 months
Other Names:
  • Hihg dose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular outcome
Time Frame: Baseline to Final visit (30 months)
The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization
Baseline to Final visit (30 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: Baseline to Final visit (30 months)
The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent
Baseline to Final visit (30 months)
Cardiac death
Time Frame: Baseline to Final visit (30 months)
The cumulative incidences of cardiac death for 30 months after percutaneous coronary intervention with drug-eluting stent
Baseline to Final visit (30 months)
Non-fatal myocardial infarction
Time Frame: Baseline to Final visit (30 months)
The cumulative incidences of non-fatal myocardial infarction for 30 months after percutaneous coronary intervention with drug-eluting stent
Baseline to Final visit (30 months)
Repeat revascularization
Time Frame: Baseline to Final visit (30 months)
The cumulative incidences of any repeat coronary revascularization for 30 months after percutaneous coronary intervention with drug-eluting stent
Baseline to Final visit (30 months)
Stent thrombosis
Time Frame: Baseline to Final visit (30 months)
The cumulative incidences of stent thrombosis categorized by ARC criteria for 30 months after percutaneous coronary intervention with drug-eluting stent
Baseline to Final visit (30 months)
Target LDL-C level achievement
Time Frame: 6 months of treatment and thereafter
The percentage of the participants who reached the LDL-C level of <70mg/dL after the treatment for 6 months.
6 months of treatment and thereafter
LDL-C level change
Time Frame: Baseline to 6 months of treatment and thereafter
The percent changes of LDL-C level from baseline to to 6 months of treatment and thereafter
Baseline to 6 months of treatment and thereafter
HDL-C level change
Time Frame: Baseline to 6 months of treatment and thereafter
The percent changes of HDL-C level from baseline to to 6 months of treatment and thereafter
Baseline to 6 months of treatment and thereafter
Level change of other biomarkers
Time Frame: Baseline to 6 months of treatment and thereafter
The percent changes of serum level of other biomarkers from baseline to to 6 months of treatment and thereafter
Baseline to 6 months of treatment and thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Samjin Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Hyung Joon Joo, MD, PhD, Department of Cardiology, Korea University Anam Hospital
  • Study Chair: Do-sun Lim, MD, PhD, Department of Cardiology, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED15175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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