UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Chronic hemodialysis Patients with Coronary Artery Disease
Title of the study (Brief title)	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	Yoshio Kobayashi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
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	Yuji Ohno
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025490