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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155530
• Other study ID #: 4-2014-0185
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: July 26, 2016
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin 40mg
homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
• pravastatin 20 mg
Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of neointimal patterns assessed by 1-year followed OCT	Qualitative neointimal pattern measured by OCT such as restenotic tissue structure	at 1 year	No
Secondary	stent coverage and neointimal thickness	Change of stent coverage and neointimal thickness assessed by 1-year followed OCT	at 1 year	Yes
Secondary	Major adverse cardiac events	MACE (Major adverse cardiac events) including cardiovascular/unexpected mortality, non-fatal myocardial infarction, target lesion revascularization	at 1 year	Yes