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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035665
Receipt No. R000040627
Scientific Title Examinations of OMT effective for prevention of MACE of the subjects with CAD and/or PAD in Japan. (Exo-MACE in Japan)
Date of disclosure of the study information 2019/02/01
Last modified on 2019/01/25

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Basic information
Public title Examinations of OMT effective for prevention of MACE
of the subjects with CAD and/or PAD in Japan.
(Exo-MACE in Japan)
Acronym Exo-MACE in Japan
Scientific Title Examinations of OMT effective for prevention of MACE
of the subjects with CAD and/or PAD in Japan.
(Exo-MACE in Japan)
Scientific Title:Acronym Exo-MACE in Japan
Region
Japan

Condition
Condition Subjects with CAD orand PAD who admitted in Yokohama City University Hospital from November 1, 2012 to June 30, 2015 are randomly assigned to the study with informed consent for clinical study (B150301009).
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Optimal medical therapy (OMT) may play an important role to prevent secondary event in coronary artery diseases (CAD) and peripheral artery diseases (PAD). However, some Japanese studies reported that beta-blockers, which are one of main components of western OMT, might result in some adverse effects. In addition, no practical pharmaceutical regimen is available for patients with PAD to prevent secondary cardio-vascular events, so far. To elucidate OMT for the subjects with prior cardiovascular diseases in Japan, we performed a quasi-randomized clinical trial using statistically proven propensity score matching and subsequent inverse probability treatment weighting methods to test which combination of medicines was most effective as the OMT to manage and prevent secondary cardiovascular events. Many studies were conducted and had reported that single medication had a significant benefit to prevent secondary events. However, only a few studies used a multi-drug regimen for prevention because it requires a lot of time, significant cost, and might be conflicting ethical concerns.
Thus, we conducted the current analyses using PS matching with the IPTW method to avoid these problems and various confounding factors. Therefore, we plan to conduct the current analyses using PS matching with the IPTW method to avoid these problems and various confounding factors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes MACE (cardiovascular death, limb amputation, non-fetal myocardial infarction, non-fetal acute coronary syndrome, non-fetal congestive heart failure, non-fetal stroke, and re-vascularization)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Optimal Medical Treatment
Interventions/Control_2 non Optimal Medical Treatment
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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects with CAD or/and PAD who admitted in Yokohama City University Hospital from November 1, 2012 to June 30, 2015 are randomly assigned to the study with informed consent for clinical study (B150301009).The subjects who admitted in Yokohama City University Hospital and are over 20 years old.
Key exclusion criteria The subjects who the attending physicians decide inappropriately.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Ishigami
Organization Yokohama City University Graduate School of Medicine, University Hospital
Division name Department of Cardiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, YOKOHAMA
TEL +81-45-787-2635
Email tommmish@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sae Teranaka
Organization Yokohama City University Graduate School of Medicine, University Hospital
Division name Department of Cardiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, YOKOHAMA
TEL +81-45-787-2635
Homepage URL
Email tommmish@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine, University Hospital
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine, University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 公立大学法人横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 02 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 Completed
Date of protocol fixation
2012 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
2015 Year 06 Month 30 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 25 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040627

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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