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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008222
Receipt No. R000009625
Scientific Title Effect of perindopril on prevention of aspiration pneumonia following severe intracerebral hemorrhage (EPOCH) study
Date of disclosure of the study information 2012/07/01
Last modified on 2012/06/27

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Basic information
Public title Effect of perindopril on prevention of aspiration pneumonia following severe intracerebral hemorrhage (EPOCH) study
Acronym EPOCH study
Scientific Title Effect of perindopril on prevention of aspiration pneumonia following severe intracerebral hemorrhage (EPOCH) study
Scientific Title:Acronym EPOCH study
Region
Japan

Condition
Condition acute intracerebral hemorrhage
Classification by specialty
Medicine in general Pneumology Neurology
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the efficacy of perindopril to prevent aspiration pneumonia following acute severe intracerebral hemorrhage
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of aspiration pneumonia in acute phase
Key secondary outcomes Modified Rankin Scale at 90 days after stroke onset
NIHSS scale at 10days after stroke onset
Blood pressure
Inflammation parameters
Duration of antibiotics use

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Medication of perindopril
Interventions/Control_2 controlgroup
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 Acute intracerebral hemorrhagic patients
1) who admit within 72 hour from onset,
2) who initiate nasal-gastric tube feeding within two days dorm admission due to altered mental state, or severe dysphagia,
3) whose age is 20 or more and less than 85 at admission,
4) whose systolic blood pressure is more than 140 mmHg,or diastolic blood pressure is more than 90 mmHg on admission
5) and whose premorbid modified Rankin scale is 2 or less.
Key exclusion criteria 1) Patients who died within 48 hours from admission,
2) Patients whose Japan coma scale is 3-200 or more, or Glasgow coma scale is 6 or less,
3) Patients who has diagnosed pneumonia before initiating nasal-gastric tube feeding,
4) Patients who has diagnosed malignant hypertension,
5) Patients who has diagnosed congestive cardiac failure with NYHA of 3 or more,
6) Patients who has took angiotensin converting enzyme inhibitor drugs,
7) Patients who are ineligible for any other reason in the opinion of the investigator.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Mori
Organization Shonan Kamakura General Hospital
Division name Deaprtment of Stroke Treatment
Zip code
Address Okamoto 1370-1, Kamakura City, Kanagawa 247-8533, Japan
TEL 0467-46-1717
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Nakazaki
Organization Shonan Kamakura General Hospital
Division name Deaprtment of Stroke Treatment
Zip code
Address Okamoto 1370-1, Kamakura City, Kanagawa 247-8533, Japan
TEL 0467-46-1717
Homepage URL
Email mstorke@nak-skgh.com

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization Shonan Kamakura General 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 湘南鎌倉総合病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 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 Preinitiation
Date of protocol fixation
2012 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 20 Day
Last modified on
2012 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009625

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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