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
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
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
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
