Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or HypertensionPhase 4NCT01502904

Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents

A Phase 4 study testing Sirolimus-eluting stent, Biolimus-eluting stents and pravastatin 20mg/day after DES implantation in people with Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
What is being tested?: Sirolimus-eluting stent, Biolimus-eluting stents and pravastatin 20mg/day after DES implantation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteSouth Korea
Study dates: Jul 2010to Jun 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital
Seoul, Seoul, 120-752

Other trials in South Korea

About this study

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.

Conditions: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Being tested: Sirolimus-eluting stent, Biolimus-eluting stents, pravastatin 20mg/day after DES implantation, pitavastatin 2mg/day after DES implantation, Non-ARB /day after DES implantation
Keywords: SES vs BES
Medical subject headings: Angina, Stable, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
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.
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.
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.
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.

Study groups in NCT01502904
Study group	Role	What they receive
Cypher group	Active comparator	Not described Receives: Device: Sirolimus-eluting stent
Nobori group	Experimental	Not described Receives: Device: Biolimus-eluting stents
Pravastatin group	Active comparator	Not described Receives: Drug: pravastatin 20mg/day after DES implantation
Pitivastatin group	Active comparator	Not described Receives: Drug: pitavastatin 2mg/day after DES implantation
Non-ARB group	Active comparator	Not described Receives: Drug: Non-ARB /day after DES implantation
ARB group	Experimental	Not described Receives: Drug: Eposartan 600mg/day after DES implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6month

Secondary outcomes (1)

stent malapposition and thrombus
The secondary endpoint of this study is to compare percent of stent malapposition and thrombus at 6 months according to specific drug treatment in 2 patient subgroups or to the types of implanted DES, SES vs. BES by a 6-month follow-up OCT.
Measured: 6month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jun 2015

First posted2 Jan 2012 (estimated)
Study startJul 2010
Primary completionMay 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or HypertensionStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01502904
Sponsor's protocol ID: 1-2010-0007
Status last verified: Jul 2016
First submitted: 29 Dec 2011
Last updated: 27 Jul 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 24835329
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.
PubMed 24531309

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents
ClinicalTrials.gov ID: NCT01502904
Acronym / sponsor ID: 1-2010-0007
Conditions: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Keywords: SES vs BES
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: Jul 2010
Primary completion: May 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 2 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
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

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sirolimus-eluting stent2x2 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.	Device	Cypher group
Biolimus-eluting stents2x2 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.	Device	Nobori group
pravastatin 20mg/day after DES implantation2x2 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.	Drug	Pravastatin group
pitavastatin 2mg/day after DES implantation2x2 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.	Drug	Pitivastatin group
Non-ARB /day after DES implantation2x2 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.	Drug	Non-ARB group
Eposartan 600mg/day after DES implantation2x2 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.	Drug	ARB group

Primary outcome

neointimal coverage
Time frame: 6month
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.

1 secondary outcome

stent malapposition and thrombus
Time frame: 6month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
Derived from this study: PubMed 24835329Kim 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.
Derived from this study: PubMed 24531309Kim 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Myeong Ki Hong, Ph.D principal investigator

Severance Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

neointimal coverage (time frame: 6month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502904, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.