NCT01502904

Brief Summary

There has been little research on neointimal coverage and malapposition after BES implantation using OCT in human coronary artery. Furthermore, specific drug may possibly influence the vascular healing after stent implantation. Therefore, this study will investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation and 2) relationship of specific drug treatment and neointimal coverage or late malapposition by the prospective, randomized study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

4.8 years

First QC Date

December 29, 2011

Last Update Submit

July 25, 2016

Conditions

Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension

Keywords

SES vs BES

Outcome Measures

Primary Outcomes (1)

  • neointimal coverage

    1. To compare the neointimal coverage on 6-month follow-up OCT according to specific drug treatment in 2 patient subgroups at 6-month after DES implantation. 2. To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation.

    6month

Secondary Outcomes (1)

  • stent malapposition and thrombus

    6month

Study Arms (6)

Cypher group

ACTIVE COMPARATOR
Device: Sirolimus-eluting stent

Nobori group

EXPERIMENTAL
Device: Biolimus-eluting stents

Pravastatin group

ACTIVE COMPARATOR
Drug: pravastatin 20mg/day after DES implantation

Pitivastatin group

ACTIVE COMPARATOR
Drug: pitavastatin 2mg/day after DES implantation

Non-ARB group

ACTIVE COMPARATOR
Drug: Non-ARB /day after DES implantation

ARB group

EXPERIMENTAL
Drug: Eposartan 600mg/day after DES implantation

Interventions

Sirolimus-eluting stentDEVICE

2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.

Cypher group
Biolimus-eluting stentsDEVICE

2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.

Nobori group
pravastatin 20mg/day after DES implantationDRUG

2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.

Pravastatin group
pitavastatin 2mg/day after DES implantationDRUG

2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.

Pitivastatin group
Non-ARB /day after DES implantationDRUG

2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.

Non-ARB group
Eposartan 600mg/day after DES implantationDRUG

2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.

ARB group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20 year old
  • In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg
  • When someone is taking Anti-Hypertensive medication
  • If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin
  • Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
  • Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention.
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
  • Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm

You may not qualify if:

  • Contraindication to anti-platelet agents
  • Proximal leison within 15 mm from ostium
  • Creatinine level 2.0 mg/dL or end stage renal disease on dialysis
  • Pregnant women or women with potential childbearing
  • Life expectancy less than 1 year
  • Complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion)
  • Vein graft lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

  • Kim JS, Ha J, Kim BK, Shin DH, Ko YG, Choi D, Jang Y, Hong MK. The relationship between post-stent strut apposition and follow-up strut coverage assessed by a contour plot optical coherence tomography analysis. JACC Cardiovasc Interv. 2014 Jun;7(6):641-51. doi: 10.1016/j.jcin.2013.12.205. Epub 2014 May 14.

    PMID: 24835329DERIVED

  • Kim BK, Ha J, Mintz GS, Kim JS, Shin DH, Ko YG, Choi D, Jang Y, Hong MK. Randomised comparison of strut coverage between Nobori biolimus-eluting and sirolimus-eluting stents: an optical coherence tomography analysis. EuroIntervention. 2014;9(12):1389-97. doi: 10.4244/EIJV9I12A236.

    PMID: 24531309DERIVED

MeSH Terms

Conditions

Angina, StableHypertension

Interventions

Pravastatinpitavastatin

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Myeong Ki Hong, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2011

First Posted

January 2, 2012

Study Start

July 1, 2010

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

KR(1)