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

Coronary Artery Disease Clinical Trial

— ROSUVA-30  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02859480
• Other study ID #: ED15175
• Status: Recruiting
• Phase: Phase 4
• First received: August 4, 2016
• Last updated: August 4, 2016
• Start date: September 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Korea University Anam Hospital
• Contact: Hyung Joon Joo, MD, PhD
• Phone: +8229205445
• Email: drjoohj[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin 5mg
Rosuvastatin 5mg tablet, q.d., for 30 months
• Rosuvastatin 20mg
Rosuvastatin 5mg tablet, q.d., for 30 months

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Samjin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular outcome	The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization	Baseline to Final visit (30 months)	Yes
Secondary	All-cause death	The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent	Baseline to Final visit (30 months)	Yes
Secondary	Cardiac death	The cumulative incidences of cardiac death for 30 months after percutaneous coronary intervention with drug-eluting stent	Baseline to Final visit (30 months)	Yes
Secondary	Non-fatal myocardial infarction	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)	Yes
Secondary	Repeat revascularization	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)	Yes
Secondary	Stent thrombosis	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)	Yes
Secondary	Target LDL-C level achievement	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	No
Secondary	LDL-C level change	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	No
Secondary	HDL-C level change	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	No
Secondary	Level change of other biomarkers	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	No