UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study of assessing platelet aggregation about patients receiving Ticagrelor with old myocardial infarction
Title of the study (Brief title)	Assessment of platelet aggregation about OMI patients receiving Ticagrelor
Region	Japan

Condition
Condition	Old myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the platelet aggregation of old myocardial infarction patients receiving meintenance dose Ticagrelor with Prasugrel using VN-P2Y12
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	To compare the average value of P2Y12 reaction units (PRU) after administration of Ticagrelor for 14 days with Prasugrel
Key secondary outcomes

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	administration of Ticagrelor
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	Old myocardial infarction patients who had emergent PCI 3 months ago.
Key exclusion criteria	Patients with contraindications against Tiacgrelor
Target sample size	35

Research contact person
Name of lead principal investigator	Yosio Kobayashi
Organization	Chiba university hospital
Division name	Cardiology
Address	Inoohana 1-8-1, chuoku, chiba
TEL	043-222-7171
Email	kazuyatateishi0926@gmail.com

Public contact
Name of contact person	Kazuya Tateishi
Organization	Chiba university hospital
Division name	Cardiology
Address	Inohana 1-8-1, chuoku, chiba
TEL	043-222-7171
Homepage URL
Email	kazuyatateishi0926@gmail.com

Sponsor
Institute	Chiba university hospital
Institute
Department

Funding Source
Organization	Self funding
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	2017 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 20 Day
Anticipated trial start date	2017 Year 12 Month 13 Day
Last follow-up date	2018 Year 08 Month 09 Day
Date of closure to data entry	2018 Year 08 Month 09 Day
Date trial data considered complete	2018 Year 09 Month 20 Day
Date analysis concluded	2018 Year 10 Month 30 Day

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Publication of results	Unpublished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

Management information
Registered date	2017 Year 07 Month 05 Day
Last modified on	2019 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032138