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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017547
Receipt No. R000020338
Scientific Title Acute phase platelet reactivity in patients with acute coronary syndrome
Date of disclosure of the study information 2015/05/13
Last modified on 2018/05/24

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Basic information
Public title Acute phase platelet reactivity in patients with acute coronary syndrome
Acronym platelet reactivity in patients with acute coronary syndrome
Scientific Title Acute phase platelet reactivity in patients with acute coronary syndrome
Scientific Title:Acronym platelet reactivity in patients with acute coronary syndrome
Region
Japan

Condition
Condition Acute Coronary syndrome
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the acute phase platelet reactivity in patients with acute coronary syndrome to be treated with prasugrel
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes The primary efficacy endpoint is the change of platelet reactivity unit (PRU) and inhibition rate which measured by VerifyNow P2Y12 platform assay.
PRU is measured before prasugrel start, and 30 minutes, one hour, 2hours, 4hours and 6hours after prasugrel loading dose(20mg), and Prasugrel maintenance dose(3.75mg) and clopidogrel maintenance dose (75mg)
Key secondary outcomes The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and the average value of the change of PRU,

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with ischemic heart disease who will undergo or have undergone percutaneous coronary intervention
2. Patients who are provided of the written agreement
3. Twenty to 85 years old
Key exclusion criteria 1. Patients with contraindications to prasugrel
2. Patients who have severe liver problem
3. Patients who have severe kidney problem
4. Weigh 45 kg or less
5. low platelet counts (less than 10*10^4)
6. Pregnant
7. Patients who are taking anticoagulants
8. Patients who are planned to administer thrombolytic agents
9. Patients scheduled for PCI or coronary artery bypass graft during this study
10. Patients who are taking ticlopidine or cilostazol
11.Cardiogenic shock
12.History of stroke or transient ischemic attack
13. Patients judged as inappropriate for trial entry
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kobayashi
Organization Chiba University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2340
Email aapa6508@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Wakabayashi
Organization Chiba University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2340
Homepage URL
Email worldpeacewaka@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba Univerity, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2015 Year 05 Month 13 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020338

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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