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

K

Korea University

Status and phase

Unknown
Phase 4

Conditions

Coronary Artery Disease
Cardiovascular Diseases
Coronary Disease

Treatments

Drug: Rosuvastatin 5mg
Drug: Rosuvastatin 20mg

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02859480
ED15175

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Rosuvastatin 5mg
Experimental group
Description:
Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention
Treatment:
Drug: Rosuvastatin 5mg
Rosuvastatin 20mg
Active Comparator group
Description:
Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention
Treatment:
Drug: Rosuvastatin 20mg

Trial contacts and locations

1

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Central trial contact

Hyung Joon Joo, MD, PhD

Data sourced from clinicaltrials.gov

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