COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial

Study Overview
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Brief Summary
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This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Atorvastatin 40mg
* Drug: pravastatin 20 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 20 years old Patients who received OCT related to clinical needs or the end point of other study Patients who received DES within 1 year before OCT evaluation Patients with homogenous or hetero neointimal pattern by OCT Non-statin user and moderate or low efficacy statin user Exclusion Criteria: Refuse to participate Contraindication to statin treatment Women with current or potential childbearing Life expectancy <1 year High efficacy statin user (Atorvastatin 80mg or Rosuvastatin 20mg)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High efficacy statin group (homogeneous)<br>homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group | Drug: Atorvastatin 40mg<br>* homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group<br>* Other names: Atorvastatin 40 mg (Homogeneous);|
| Active Comparator: Low efficacy statin group (homogeneous)<br>homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group | Drug: pravastatin 20 mg<br>* Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group<br>* Other names: Pravastatin 20 mg (Homogeneous);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of neointimal patterns assessed by 1-year followed OCT | Qualitative neointimal pattern measured by OCT such as restenotic tissue structure | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent coverage and neointimal thickness | Change of stent coverage and neointimal thickness assessed by 1-year followed OCT | at 1 year | 
| Major adverse cardiac events | MACE (Major adverse cardiac events) including cardiovascular/unexpected mortality, non-fatal myocardial infarction, target lesion revascularization | at 1 year |