UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017547 |
|---|---|
| Receipt number | 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 16:29:08 |
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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
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
worldpeacewaka@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020338
| 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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| Registered date | File name |
