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

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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 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

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

Value
https://center6.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