UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and eficity of 2.5mg prasugrel therapy in the eldely or low body weight Japanese patients undergoing percutaneous coronary intervention
Title of the study (Brief title)	2.5mg Prasugrel therapy in the eldely or low body weight Japanese 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 safety and efficacy 2.5mg dose of prasugrel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The primary efficacy endpoint is the variation in the rate of low on-treatment platelet reactivity (LPR) among Prasugrel 3.75 mg and prasugrel 2.5 mg maintenance dose. We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU < 95 for LPR
Key secondary outcomes	The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and optimal on treatment platlet reactivity (OPR) amomg clopidogrel 75 mg maintenance dose , prasugrel 3.75 mg maintenance dose and prasugrel 2.5mg maintenance dose, the difference of the mean PRU and mean inhibition rate, the average value of the change of PRU, the relation between coronary stent and platlet inhibition, the relation between date from InBody S20 and platelet inhibition and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to BARC criteria, ischemic events, stent thrombosis, myocardial infarction during this study.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Change from 3.75mg to 2.5mg Prasugrel
Interventions/Control_2	Change from 2.5mg to 3.75mg Prasugrel
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	Not applicable
Age-upper limit	Not applicable
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 taking both aspirin and clopidogrel 3. Patients who are provided of the written agreement 4. Over 75 years old and/or less than 50kg 5. At least four weeks after an ACS event 6. Four weeks or more after PCI or coronary artery bypass graft
Key exclusion criteria	1. Patients with contraindications to prasugrel 2. Patients who have severe liver problem 3. Patients who have severe kidney problem 4. History of stroke or transient ischemic attack 5. low platelet counts (less than 10*10^4) 6. Patients who are taking anticoagulants 7. Patients who are planned to administer thrombolytic agents 8. Patients scheduled for PCI or CABG during this study 9. Patients who are taking ticlopidine or cilostazol or prasugrel. 10. Patients judged as inappropriate for trial entry
Target sample size	70

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	aapa6508@chiba-u.jp

Public contact
Name of contact person	Shinichi Wakabayashi
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	worldpeacewaka@yahoo.co.jp

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	千葉大学医学部付属病院(千葉県)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 09 Month 28 Day
Anticipated trial start date	2015 Year 10 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 20 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022460