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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022139
Receipt No. 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

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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
Email 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
Email yuji.o.chiba@gmail.com

Sponsor
Institute Chiba University Hospital
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025490

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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