UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023448
Receipt No. 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

* 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
Email 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
Email hkitahara@chiba-u.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.