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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02155530

Enrollment

Registered

2014-06-04

Start date

2014-06-30

Completion date

2016-06-30

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DRUGAtorvastatin 40mg

homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group

DRUGpravastatin 20 mg

Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026