UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023448 |
|---|---|
| Receipt number | R000026837 |
| Scientific Title | Impact of lipid-lowering therapy with Evolocumab on coronary plaque regression in patients with coronary artery disease |
| Date of disclosure of the study information | 2016/08/30 |
| Last modified on | 2019/05/15 16:05:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of lipid-lowering therapy with Evolocumab on coronary plaque regression in patients with coronary artery disease
Acronym
Impact of Evolocumab on coronary plaque regression
Scientific Title
Impact of lipid-lowering therapy with Evolocumab on coronary plaque regression in patients with coronary artery disease
Scientific Title:Acronym
Impact of Evolocumab on coronary plaque regression
Region
| Japan |
Condition
Condition
Patients with coronary artery disease requiring percutaneous coronary intervention (PCI), and with LDL-C >= 100 mg/dl even on statin therapy for at least 4 weeks
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether reduction of LDL-C by Evolocmab induces coronary plaque regression in patients with coronary artery disease requiring PCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in percent atheroma volume (PAV) in non-culprit lesions from baseline to follow-up (12 months after PCI) as measured by intravascular ultrasound (IVUS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intravascular ultrasound (and optical coherence tomography, if possible) will be performed to observe coronary plaque of non-culprit lesions at follow-up coronary angiography 12 months after stent implantation.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with coronary artery disease requiring percutaneous coronary intervention
2) Patients with LDL-C >= 100 mg/dl even on statin therapy for at least 4 weeks, either with or without familial hypercholesterolemia
3) 20 to 85 years old
4) Signed written informed consent
Key exclusion criteria
1) Difficulty to observe the coronary arteries, including non-culprit lesions, by IVUS at PCI procedure
2) Severe hepatic insufficiency
3) Severe renal insufficiency
4) Severe heart failure (left ventricular ejection fraction <30%, or NYHA class III or IV)
5) intolerance or allergy to statin
6) Pregnant, postpartum within 28 days, or breast-feeding
7) Recognized as inadequate by attending doctor
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba, Japan
TEL
043-222-7171
yuiryosuke@msn.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kitahara |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
hkitahara@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Abbott Vascular Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana Chuo-ku, Chiba, Japan
Tel
043-222-7171
chibacrc@mac.com
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
3
Results
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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026837
