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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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Atorvastatin 40mg

pravastatin 20 mg

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High efficacy statin group (homogeneous)

Low efficacy statin group (homogeneous)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of neointimal patterns assessed by 1-year followed OCT

Qualitative neointimal pattern measured by OCT such as restenotic tissue structure

Secondary Outcome Measures

stent coverage and neointimal thickness

Change of stent coverage and neointimal thickness assessed by 1-year followed OCT

Major adverse cardiac events

MACE (Major adverse cardiac events) including cardiovascular/unexpected mortality, non-fatal myocardial infarction, target lesion revascularization

Full Information

NCT ID

NCT02155530

First Posted

May 26, 2014

Last Updated

July 26, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02155530

Brief Title

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High efficacy statin group (homogeneous)

Arm Type

Experimental

Arm Description

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

Arm Title

Low efficacy statin group (homogeneous)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 40mg

Other Intervention Name(s)

Atorvastatin 40 mg (Homogeneous)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

pravastatin 20 mg

Other Intervention Name(s)

Pravastatin 20 mg (Homogeneous)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of neointimal patterns assessed by 1-year followed OCT

Description

Qualitative neointimal pattern measured by OCT such as restenotic tissue structure

Time Frame

at 1 year

Secondary Outcome Measure Information:

Title

stent coverage and neointimal thickness

Description

Change of stent coverage and neointimal thickness assessed by 1-year followed OCT

Time Frame

at 1 year

Title

Major adverse cardiac events

Description

MACE (Major adverse cardiac events) including cardiovascular/unexpected mortality, non-fatal myocardial infarction, target lesion revascularization

Time Frame

at 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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