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

July 26, 2016 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High efficacy statin group (homogeneous)
homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
Drug: Atorvastatin 40mg
homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
Other Names:
  • Atorvastatin 40 mg (Homogeneous)
ACTIVE_COMPARATOR: Low efficacy statin group (homogeneous)
homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
Drug: pravastatin 20 mg
Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
Other Names:
  • Pravastatin 20 mg (Homogeneous)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (ESTIMATE)

June 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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