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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028739
Receipt No. R000032889
Scientific Title Clinical trial of prevention for PCI-related myocardial infarction evaluating index of microvascular resistance in stable coronary artery disease. -Effect of Fasudil, a selective Rho-kinase inhibitor-
Date of disclosure of the study information 2017/10/01
Last modified on 2019/03/02

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Basic information
Public title Clinical trial of prevention for PCI-related myocardial infarction evaluating index of microvascular resistance in stable coronary artery disease. -Effect of Fasudil, a selective Rho-kinase inhibitor-
Acronym Clinical trial of prevention for PCI-related myocardial infarction evaluating index of microvascular resistance in stable coronary artery disease. -Effect of Fasudil, a selective Rho-kinase inhibitor-
Scientific Title Clinical trial of prevention for PCI-related myocardial infarction evaluating index of microvascular resistance in stable coronary artery disease. -Effect of Fasudil, a selective Rho-kinase inhibitor-
Scientific Title:Acronym Clinical trial of prevention for PCI-related myocardial infarction evaluating index of microvascular resistance in stable coronary artery disease. -Effect of Fasudil, a selective Rho-kinase inhibitor-
Region
Japan

Condition
Condition stable coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to adress wheter Fasudil, a selective Rho-kinase inhibitor, could prevent PCI-related myocardial infarction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes index of microvascular resistance
Key secondary outcomes high sensitive troponin T

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 intracoronary single administration of 30mg of Fasudil
Interventions/Control_2 intracoronary single administration of normal saline
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
100 years-old >
Gender Male and Female
Key inclusion criteria (1)stable coronary artery disease
(2)stenosis in left coronary artery
(3)pressure wire enable to pass the lesion
(4)20 years old and older
(5)male or female
Key exclusion criteria (1) severe anemia or infection, malignancy, decompensated congestive heart failure
(2) previous myocardial infarction in the target vessel
(3) target vessel is a donar or recipient of collateral artery
(4)systolic blood pressure under 80mmHg
(5)bronchial asthma or allergy for adenosin triphosphate
(6) left main coronary trunk lesion or severe stenosis with contrast delay
(7) severe renal or liver dysfunction
(8) allergy for Fasudil
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University
Division name Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Zip code
Address 1-1, Seiryouchou, Aobaku, Sendai City
TEL 022-7171-7153
Email shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoku Kikuchi
Organization Tohoku University
Division name Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Zip code
Address 1-1, Seiryouchou, Aobaku, Sendai City
TEL 022-717-7153
Homepage URL
Email ykikuchi911@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Organization
Division
Category of Funding Organization Other
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
2017 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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
2017 Year 08 Month 18 Day
Last modified on
2019 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032889

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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