UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022548 |
|---|---|
| Receipt number | R000025989 |
| Scientific Title | Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2019/02/12 16:54:39 |
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Basic information
Public title
Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI
Acronym
Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI
Scientific Title
Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI
Scientific Title:Acronym
Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI
Region
| Japan |
Condition
Condition
effort angina pectoris or asymptomatic myocardial ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether values of coagulometer are clinically useful for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI, by analyzing the changed volume in PRU and coagulometer values and their correlation before and after administration of two antiplatelet medicines including prasugrel
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between values of PRU and the coagulometer
Key secondary outcomes
1. Amount changed in coagulometer values
2. Subgroup analysis by the changed amount of coagulometer values
3. Correlation between coagulometer values and patients' background data
4. Subgroup analysis by coagulometer values
5. Safety of the study drugs (frequency of adverse events)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included in this study.
1. PCI is scheduled due to having effort angina pectoris or asymptomatic myocardial ischemia
2. Currently not on any antiplatelet medicines (excepting aspirin)
3. Patients who are at age of 20 or older when providing their written consent (both male and female)
4. Patients can give their consent in a written form
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study.
1. At high risks of bleeding
2. Have an experience of hypersensitivity to aspirin or prasugrel in the past
3. Currently pregnant, or possibly pregnant, or planning to be pregnant during the study
4. Had used P2Y12 inhibitor within two weeks before providing written consent
5. Have been prescribed with antiplatelets such as clopidogrel, cilostazol, sarpogrelate hydrochloride, etc. excluding aspirin
6. Currently on any anticoagulant, or planning to use an anticoagulant
7. Had joined other clinical study within the last month or currently being part of a clinical study, or planning to join other study while participating in this study
8. Other condition that the researcher thinks the participant is inappropriate to participate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Mitsuaki Isobe |
Organization
Tokyo Medical and Dental University
Division name
Cardiovascular Medicine, Medical Hospital
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
isobemi.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
Address
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo 101-0052
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
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
| 2016 | Year | 05 | Month | 31 | 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
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
This is a pilot study which attempts to evaluate the clinical usefulness of dielectric coagulometer to monitor the efficacy of using antiplatelet medicine in patients undergone elective PCI by analyzing the correlation between values of PRU and coagulometer. The study drugs are prasugrel and aspirin, and the target number of our subjects is 50 patients who are scheduled to have PCI.
* Study design
This is a prospective, observational study carried out at one research institute. We only have one study group with two observation points (baseline and 4th week); no comparison groups are included in this study. The study period ends on July 31, 2017.
* Subjects recruitment
Patients visit the hospital and meet the inclusion criteria are qualified to be the participants of this study. Of those who are able to give their consent in a written form are enrolled. The enrollment period is until May 30, 2017.
* Evaluation items
1. Background information of the subjects
Age, sex, height, body weight, BMI, blood pressure, abdominal circumference, history of smoking, medication intake, anamnesis, and comorbidity
2. General medical checkup
Vital sign, blood test
3. Information on Medication
Regarding information of medicines taken during the study period
4. Platelet aggregation activity:
Values of PRU and coagulometer are assessed by VerifyNow(R) and dielectric coagulometer(R), respectively.
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025989
