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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035103
Receipt No. R000035064
Official scientific title of the study 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

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Basic information
Official scientific title of the study High-density Lipoprotein Cholesterol as a Therapeutic Target for Residual Risk in Patients With Acute Coronary Syndrome
Title of the study (Brief title) 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 Takashi Akasaka
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
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 Yuichi Ozaki
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL 073-441-0621
Homepage URL
Email yozaki@wakayama-med.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Published
URL releasing results https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0200383
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.
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
URL(English) https://upload.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


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