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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015192
Receipt No. 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

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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
Email 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
Email takayama.tadateru@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017659

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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