UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031990
Receipt number R000036517
Scientific Title Impact of evolocumab on periprocedural microvascular damage in patients undergoing percutaneous coronary intervention (PCI)
Date of disclosure of the study information 2018/03/29
Last modified on 2018/07/20 11:14:37

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Basic information

Public title

Impact of evolocumab on periprocedural microvascular damage in patients undergoing percutaneous coronary intervention (PCI)

Acronym

EVOLUTION Trial

Scientific Title

Impact of evolocumab on periprocedural microvascular damage in patients undergoing percutaneous coronary intervention (PCI)

Scientific Title:Acronym

EVOLUTION Trial

Region

Japan


Condition

Condition

stable coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of evolocumab on coronary microvascular function after PCI when administered to angina patients with high LDL-C levels

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Index of microvascular resistance after PCI

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Evolocumab

Interventions/Control_2

standard of care

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 aged 20 to 85 years at the time of informed consent.
(2) Patients with stable coronary artery disease who are planned to undergo PCI.
(3) Patients with high LDL-C levels after at least 2-week treatment of high-dose statin
(4) Patients who are capable of providing written consent.

Key exclusion criteria

(1) Any prior use of PCSK9 inhibitor therapy.
(2) Patients with previous MI in the terriory of the target coronary artery.
(3) Patients with target vessels which are two, three, or LMT.
(4) Patients with recent MI in past 6 weeks
(5) Patients with heart failure of New York Heart Failure Association class III or IV
(6) Patients with last known left ventricular ejection fraction <30%.
(7) Patients with serious renal impairment with an eGFR <30 mL/min/1.73 m2 at screening
(8) Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal (ULN) at screening
(9) Patients who are pregnant, possibly pregnant, or breast feeding.
(10) Patients who have been enrolled in other clinical studies at the same time with this study (excluding observational studies such as registry studies).
(11) Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaharu Ishihara

Organization

Hyogo College of Medicine

Division name

Internal Medicine, Division of Coronary Artery Disease

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501 Japan

TEL

0798-45-6553

Email

ma-ishihara@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Asakura

Organization

Hyogo College of Medicine

Division name

Internal Medicine, Cardiovascular Division

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501 Japan

TEL

0798-45-6553

Homepage URL


Email

ma-asakura@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Astellas Amgen(scheduled)

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


Address


Tel


Email



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 03 Month 29 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


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

Preinitiation

Date of protocol fixation

2018 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2018 Year 04 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



Management information

Registered date

2018 Year 03 Month 29 Day

Last modified on

2018 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036517


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name