UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035103
Receipt number R000035064
Scientific Title High-density Lipoprotein Cholesterol as a Therapeutic Target for Residual Risk in Patients With Acute Coronary Syndrome
Date of disclosure of the study information 2018/12/02
Last modified on 2018/12/02 00:31:45

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Basic information

Public title

High-density Lipoprotein Cholesterol as a Therapeutic Target for Residual Risk in Patients With Acute Coronary Syndrome

Acronym

High-density Lipoprotein Cholesterol as a Therapeutic Target for Residual Risk in Patients With Acute Coronary Syndrome

Scientific Title

High-density Lipoprotein Cholesterol as a Therapeutic Target for Residual Risk in Patients With Acute Coronary Syndrome

Scientific Title:Acronym

High-density Lipoprotein Cholesterol as a Therapeutic Target for Residual Risk in Patients With Acute Coronary Syndrome

Region

Japan


Condition

Condition

Patients with acute coronary syndrome with a history of having undergone successful percutaneous coronary intervention

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the impact of high-density lipoprotein cholesterol levels on plaque stabilization using OCT (Optical Coherence Tomography).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in coronary fibrous-cap thickness

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with acute coronary syndrome (defined as ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina). Patients who meet at least two of the following criteria within 7 days prior to admission:
1. ECG changes of acute coronary ischemia
2. SerumCK level more than 2 times the upper limit of normal, serum CK-MB or troponin (T/I) over the above upper limit of normal, or positivity for serum troponin T by a rapid, qualitative assay
3. Clinical history or pathological findings of acute myocardial infarction.
2) Patients who have at least one coronary plaque involving 25% or more of the stenosis (at the culprit lesion, the plaque needs to be 10 mm or more away from the PCI lesion)
3) Patients with hypercholesterolemia as defined by either of the criteria below
1.LDL-C>=140mg/dL
2.LDL-C>=100mg/dL and patients who are judged by the investigator as needing cholesterol-lowering treatment by the investigator
4) Patients 20 years old or older at the time of provision of consent
5) Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study

Key exclusion criteria

1) Target PCI lesion is graft stenosis or in-stent restenosis
2) Patients who had undergone previous PCI for the lesion under evaluation.
3) Patients who have plaque in a non-culprit site on the PCI vessel that might call for PCI during the treatment period (non-culprit lesion is unrestricted)
4) Patients already receiving lipid lowering agents (HMG-CoA reductase inhibitors [statins], fibrates, probucol, nicotinic acid, anion exchange resins, or ezetimib)
5) Patients with familial hypercholesterolemia
6) Patients with cardiogenic shock
7) Patients on cyclosporine therapy
8) Patients with liver dysfunction (ALT[GPT] >= 100IU), biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus
9) Pregnant and possibly pregnant women, lactating women
10) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or on maintenance dialysis
11) Patients who are judged by the principal or other investigator to be ineligible for enrollment in the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Akasaka

Organization

Wakayama Medical University

Division name

Department of Cardiovascular Medicine

Zip code


Address

811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan

TEL

073-441-0621

Email

akasat@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Ozaki

Organization

Wakayama Medical University

Division name

Department of Cardiovascular Medicine

Zip code


Address

811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan

TEL

073-441-0621

Homepage URL


Email

yozaki@wakayama-med.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0200383

Number of participants that the trial has enrolled


Results

No differences were observed in the baseline LDL-C and HDL-C levels between the two groups. Reduction of LDL-C levels and increase of HDL-C levels were greater in the responder group. On multivariate logistic regression analysis, LDL-C levels (OR: 0.956, 95% CI: 0.921-0.993; p=0.020) and HDL-C levels (OR: 1.143; 95% CI: 1.005-1.300, p=0.041) were independent contributors for plaque stabilization.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

HDL-C could be a therapeutic target for residual risk management in ACS patients.


Management information

Registered date

2018 Year 12 Month 02 Day

Last modified on

2018 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name