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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Atorvastatin 40mg; Drug: pravastatin 20 mg

• Registration Number: NCT02155530
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-05-26
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High efficacy statin group (homogeneous)	Atorvastatin 40mg	homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
Low efficacy statin group (homogeneous)	pravastatin 20 mg	homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group

Primary Outcome Measures

Name	Time	Method
Change of neointimal patterns assessed by 1-year followed OCT	at 1 year	Qualitative neointimal pattern measured by OCT such as restenotic tissue structure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of