UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028739 |
|---|---|
| Receipt number | 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 | 2025/03/03 15:05:45 |
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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
Double blind -all involved are 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 | jun |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University
Division name
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Zip code
980-8574
Address
1-1, Seiryouchou, Aobaku, Sendai City
TEL
022-7171-7153
jtakahashi@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoku |
| Middle name | |
| Last name | Kikuchi |
Organization
Tohoku University
Division name
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Zip code
980-8574
Address
1-1, Seiryouchou, Aobaku, Sendai City
TEL
022-717-7153
Homepage URL
ykikuchi911@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
Institute
Department
Personal name
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
Ethics Committee of Tohoku University Hospital
Address
1-1, Seiryouchou, Aobaku, Sendai City
Tel
022-728-4105
rinri-2@proj.med.tohoku.ac.jp
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
23
Results
We investigated whether administration of 30 mg of Fasudil in advance, a selective Rho-kinase inhibitor dilating coronary microvasculature, could suppress the occurrence of PCI related myocardial injury due to microvascular embolization, assessing IMR before and after PCI. Twenty-three patients were enrolled and divided into the placebo group or the Fasudil group. No significant difference was observed with respect to IMR and the level of Troponin-T between the Fasudil and the placebo groups.
Results date posted
| 2025 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age was 75 years old, 78% of participants were male.
Prevalence of hypertension, diabetes mellitus, dyslipidemia was 70%, 30% and 74%, respectively.
Mean systolic blood pressure was 132 mmHg, and mean diastolic blood pressure was 74 mmHg.
Most of the target vessels were left anterior descending artery (83%), and the rest were left circumflex artery (17%).
Participant flow
Twenty-three patients were enrolled and underwent randomization.
Eleven patients were assigned to the placebo group and twelve to the Fasudil group. All participants completed the study.
Adverse events
None
Outcome measures
There was no significant difference in IMR after PCI between the two groups. Also, IMR at baseline, that after Fasudil (or placebo) administration, and that after PCI were similar in the each groups. No significant difference was observed with respect to Troponin-T elevation after PCI between the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032889
