UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015192 |
|---|---|
| Receipt number | R000017659 |
| Scientific Title | Effect of prasugrel for stent implantation in patients with acute coronary syndrome |
| Date of disclosure of the study information | 2014/10/17 |
| Last modified on | 2019/03/22 10:47:48 |
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Basic information
Public title
Effect of prasugrel for stent implantation in patients with acute coronary syndrome
Acronym
Prasugrel fo ACS study (PACS Study)
Scientific Title
Effect of prasugrel for stent implantation in patients with acute coronary syndrome
Scientific Title:Acronym
Prasugrel fo ACS study (PACS Study)
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of prasugrel the patient with ACS ungergoing PCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between aggregation of platelet(PRU) and bio-markers of myocardium.
Key secondary outcomes
1.The relationship between aggregation of platelet(PRU) and angioscopic findings
2.The relationship between aggregation of platelet(PRU) an genottpe of CYP2C19
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prasugrel
Interventions/Control_2
clopidogrel
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
1) >= 20 years old, male and female
2) patients with ACS
3) patients underwent stent implantation
4) written informed concent
Key exclusion criteria
1) on going bleeding
2) drug allergy due to study drug
3) pregnancy
4) appropriate patients decided by the doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hirayama |
Organization
Nihon University school of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
Address
30-1 Oyaguchi kamichou, Itabashiku, Tokyo, Japan
TEL
03-3972-8111
hirayama.atsushi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadateru Takayama |
Organization
Nihon University
Division name
Division of Cardiology, Department of Medicine
Zip code
Address
30-1 Oyaguchi Kamichou, Itabashiku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
takayama.tadateru@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 10 | Month | 17 | 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
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017659
