UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022139 |
|---|---|
| Receipt number | R000025490 |
| Scientific Title | Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Chronic hemodialysis Patients with Coronary Artery Disease |
| Date of disclosure of the study information | 2016/04/29 |
| Last modified on | 2017/10/30 12:07:39 |
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Basic information
Public title
Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Chronic hemodialysis Patients with Coronary Artery Disease
Acronym
Switching from Clopidogrel to Prasugrel in Dialysis Patients
Scientific Title
Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Chronic hemodialysis Patients with Coronary Artery Disease
Scientific Title:Acronym
Switching from Clopidogrel to Prasugrel in Dialysis Patients
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the platelet inhibition after switching from maintenance clopidogrel to prasgurel.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoint is the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose.
We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU > 208 for HPR and PRU < 95 for LPR, respectively.
Key secondary outcomes
The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose and 2 weeks after switching again from prasugrel 3.75 mg to clopidogrel 75 mg, the difference of the mean PRU and mean inhibition rate between clopidogrel 75 mg and prasugrel 3.75 mg, the average value of the change of PRU, and the relation between CYP2C19 polymorphism and platelet inhibition.
The safety endpoints are the rate of bleeding events according to TIMI bleeding criteria, ischemic events, stent thrombosis, myocardial infarction during this study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from Maintenance Clopidogrel to Prasgurel
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients on regular maintenance hemodialysis for > 6 months and three times a week.
2. Patients with ischemic heart disease who will undergo or have undergone percutaneous coronary intervention
3. Patients who are taking both aspirin and clopidogrel for more than 14 days
4. Patients who are provided of the written agreement
5. Twenty to 80 years old
6. At least four weeks after an ACS event
7. Four weeks or more after PCI or coronary artery bypass graft
8. Patients whose hemodialysis characteristics are not changed more than 2 weeks.
Key exclusion criteria
1. Patients with contraindications to prasugrel
2. Patients who have severe liver problem
3. Weight is 50 kg or less
4. low platelet counts (less than 10*10^4)
5. Pregnant
6. Lactating
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. Patents who are planed to change hemodialysis characteristics during this study
11. Patients who are taking ticlopidine or cilostazol
12. Patients judged as inappropriate for trial entry
Target sample size
41
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
yoshio.kobayashi@wonder.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Ohno |
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
yuji.o.chiba@gmail.com
Sponsor or person
Institute
Chiba University Hospital
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
| 2016 | Year | 04 | Month | 29 | 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 | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 29 | Day |
Last modified on
| 2017 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025490
