UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018437 |
|---|---|
| Receipt number | R000021346 |
| Scientific Title | Evaluation of association between PCI-related myocardial infarction and platelet reactivity in patients undergoing elective PCI |
| Date of disclosure of the study information | 2015/09/20 |
| Last modified on | 2018/06/28 09:28:40 |
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Basic information
Public title
Evaluation of association between PCI-related myocardial infarction and platelet reactivity in patients undergoing elective PCI
Acronym
Evaluation of association between PCI-related myocardial infarction and platelet reactivity in patients undergoing elective PCI(OMATI study)
Scientific Title
Evaluation of association between PCI-related myocardial infarction and platelet reactivity in patients undergoing elective PCI
Scientific Title:Acronym
Evaluation of association between PCI-related myocardial infarction and platelet reactivity in patients undergoing elective PCI(OMATI study)
Region
| Japan |
Condition
Condition
atable effort angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pilot study to evaluate association between PCI-related myocardial infarction and platelet reactivity in patients undergoing elective PCI
Basic objectives2
Others
Basic objectives -Others
Evaluation of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between PCI-related myocardial infarction and platelet reactivity by VerifyNow in patients undergoing elective PCI
Key secondary outcomes
Association between bleeding or composite cardiovascular events and platelet reactivity by VerifyNow in patients undergoing elective PCI within 30 days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prasugrel 3.75mg/day
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) patients with stable effort agina pectoris to whom elective PCI is planned.
(b)patients aged over 20 and under 80 years old.
(c)Body weight over 50kg
(d)patients receiving prasugrel for more than one week.
Key exclusion criteria
(a) patients wiht bleeding tendency
(b) severe liver dysfunction
(c) severe renal dysfunction including hemodialysis
(d) uncontroled hypertensive patients
(e) patients with prior cerebral infarction or transient ischemic attack
(f) patients with allagy against thienopyridine drugs
(g)patients using rotabureta during PCI
(h)patients who are not suitable for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Okayama Uni
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Cardiovascular Medicine,Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY
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
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
| 2015 | Year | 09 | Month | 20 | 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
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | 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
A pilot study
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021346
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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