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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 27, 2016
July 1, 2016
1.9 years
May 26, 2014
July 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change of neointimal patterns assessed by 1-year followed OCT
Qualitative neointimal pattern measured by OCT such as restenotic tissue structure
at 1 year
Secondary Outcomes (2)
stent coverage and neointimal thickness
at 1 year
Major adverse cardiac events
at 1 year
Study Arms (2)
High efficacy statin group (homogeneous)
EXPERIMENTALhomogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
Low efficacy statin group (homogeneous)
ACTIVE COMPARATORhomogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
Interventions
homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2014
First Posted
June 4, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
July 27, 2016
Record last verified: 2016-07