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

NCT ID: NCT02155530

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High efficacy statin group (homogeneous)

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

Group Type: EXPERIMENTAL

Atorvastatin 40mg

Intervention Type: DRUG

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

Low efficacy statin group (homogeneous)

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

Group Type: ACTIVE_COMPARATOR

pravastatin 20 mg

Intervention Type: DRUG

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

Interventions

Atorvastatin 40mg

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

Intervention Type: DRUG

pravastatin 20 mg

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

Intervention Type: DRUG

Other Intervention Names

Atorvastatin 40 mg (Homogeneous); Pravastatin 20 mg (Homogeneous)

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0185

Identifier Type: -

Identifier Source: org_study_id