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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031990
Receipt No. 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

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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
Institute Hyogo College of Medicine
Institute
Department

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
URL(English) https://upload.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


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