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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Coronary Disease Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin 5mg

Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention

Group Type EXPERIMENTAL

Rosuvastatin 5mg

Intervention Type DRUG

Rosuvastatin 5mg tablet, q.d., for 30 months

Rosuvastatin 20mg

Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention

Group Type ACTIVE_COMPARATOR

Rosuvastatin 20mg

Intervention Type DRUG

Rosuvastatin 5mg tablet, q.d., for 30 months

Interventions

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Rosuvastatin 5mg

Rosuvastatin 5mg tablet, q.d., for 30 months

Intervention Type DRUG

Rosuvastatin 20mg

Rosuvastatin 5mg tablet, q.d., for 30 months

Intervention Type DRUG

Other Intervention Names

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Low dose group Hihg dose group

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No