Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months. Study Design.

Detailed Description
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Objective: To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months. Study Design Prospective, randomized, multi-center study of each 1000 subjects enrolled. Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period. Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.

Official Title
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Effects of High-dose Statin Treatments on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Drug-eluting Stents Implantation: a Randomized Controlled Study

Conditions
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Drug-eluting Stent (DES)

Intervention / Treatment
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* Drug: Atorvastatin (High dose statin treatment)
* Drug: Pravastatin (High dose statin treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had previously received DES at least 12 months(±2month) ago Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation Patients with mono antiplatelet therapy with only aspirin after Age 20 years of older Patients with signed informed consent Exclusion Criteria: History of DES or BMS implantation within 10 months Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects Pregnant women or women with potential childbearing Life expectancy ≤ 2 year

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin group<br>Atorvastatin 40 mg daily for 12 months after randomization | Drug: Atorvastatin (High dose statin treatment)<br>* Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program Atorvastatin 40 mg daily for 12 months after randomization<br>* Other names: DES-statin;|
| Active Comparator: Pravastatin group<br>Pravastatin 20mg daily for 12 months after randomization | Drug: Pravastatin (High dose statin treatment)<br>* Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program Pravastatin 20mg daily for 12 months after randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composite of death from any cause | Occurrence of the composite of death from any cause, MI, target vessel revascularization (TVR, either by PCI or CABG), non-TVR, stent thrombosis (ST), peripheral artery intervention, deterioration of renal function, stroke or admission for significant clinical cardiac events for 12 months following the randomization to the assigned statin therapy. | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac or non-cardiac death | Major determinant for the occurrence of major events(death,MI,TVR,ST) Comparisons of the occurrence of major events according to the attainment of recommended LDL-C goal on current lipid guideline Association between laboratory test and clinical outcomes; Sub-study according to the subsets of disease Association between parameters at index procedure and clinical outcomes | 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High dose statin