UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008222 |
|---|---|
| Receipt number | 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 14:22:06 |
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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
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
mstorke@nak-skgh.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009625
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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