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OpenTrials
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NCT Number: NCT02155530

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Atorvastatin 40mg

Drug

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

Other names: Atorvastatin 40 mg (Homogeneous)

pravastatin 20 mg

Drug

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

Other names: Pravastatin 20 mg (Homogeneous)

Primary outcomes

  1. 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

Secondary outcomes

  1. stent coverage and neointimal thickness

    Time frame: at 1 year

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

  2. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2014
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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