UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Acute phase platelet reactivity in patients with acute coronary syndrome
Title of the study (Brief title)	platelet reactivity in patients with acute coronary syndrome
Region	Japan

Condition
Condition	Acute Coronary syndrome
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the acute phase platelet reactivity in patients with acute coronary syndrome to be treated with prasugrel
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	The primary efficacy endpoint is the change of platelet reactivity unit (PRU) and inhibition rate which measured by VerifyNow P2Y12 platform assay. PRU is measured before prasugrel start, and 30 minutes, one hour, 2hours, 4hours and 6hours after prasugrel loading dose(20mg), and Prasugrel maintenance dose(3.75mg) and clopidogrel maintenance dose (75mg)
Key secondary outcomes	The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and the average value of the change of PRU,

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	85 years-old >=
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 provided of the written agreement 3. Twenty to 85 years old
Key exclusion criteria	1. Patients with contraindications to prasugrel 2. Patients who have severe liver problem 3. Patients who have severe kidney problem 4. Weigh 45 kg or less 5. low platelet counts (less than 10*10^4) 6. Pregnant 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. Patients who are taking ticlopidine or cilostazol 11.Cardiogenic shock 12.History of stroke or transient ischemic attack 13. Patients judged as inappropriate for trial entry
Target sample size	50

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
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	2015 Year 05 Month 13 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 08 Month 27 Day
Anticipated trial start date	2014 Year 10 Month 24 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	Prospective study

Management information
Registered date	2015 Year 05 Month 13 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=R000020338