UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Controlled Anti-platelet medical therapy based on rapid CYP2C19 gene evaluation in Acute myocardial infarction
Title of the study (Brief title)	CALDERA-GENE STUDY
Region	Japan

Condition
Condition	Acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to establish a optimal anti-platelet therapy by choosing the dose of anti-platelet agents based on the result of Spartan RX CYP2C19 DNA testing system after emergent percutaneous coronary intervention(PCI) in acute myocardial infarction(AMI). Further more, we examine the effect of clopidogrel resistance on the platelet function test and the biomarkers for blood coagulation in these patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.The frequency of CYP2C19 *2, *3, and *17 polymorphism in acute myocardial infarction. 2.Difference of several change in the residual platelet aggregation and the biomarkers for blood coagulation and cardiac biomarkers.
Key secondary outcomes	Composite cardiovascular events(cardiac death, fatal and non fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular event, percutaneous coronary intervention or coronary artery bypass graft, hospitalization for heart failure, deep vein thrombosis, pulmonary thromboembolism, hospitalization for peripheral arterial disease, hemorrhagic complication)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Non-carriers of CYP2C19 reduced function allele with standard dual anti-platelet therapy(asprin 100mg + clopidogrel 75mg)
Interventions/Control_2	Carriers of CYP2C19 reduced function allele with standard dual anti-platelet therapy (asprin 100mg + clopidogrel 75mg)
Interventions/Control_3	Carriers of CYP2C19 reduced function allele with triplet antiplatelet therapy (asprin 100mg + clopidogrel 75mg + cilostazol 200mg)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ST elevation myocardial infarction and non ST elevation myocrdial ingarction who underwent emergent percutaneous coronary intervention.
Key exclusion criteria	We exclude patients with deep vein thrombosis, cerebral infarction, atrial fibrillation, collagen disease ,disseminated intravascular coagulation, sepsis, severe infection and malignant diseases. We exclude patients who were treated with warfarin, steroids, thrombolytic agents, ticlopidine, sarpogrelate or cilostazol. We exclude patients with severe liver or renal dysfunction. We exclude patients who need mechanical cardio-plumonary supports such as intraaortic balloon pumping(IABP) or percutaneous cardiopulmonary support(PCPS).
Target sample size	100

Research contact person
Name of lead principal investigator	Hisao Ogawa
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Cardiovascular medicine
Address	Honjo 1-1-1, Chuo-ku, Kumamoto, Japan
TEL	096-373-5175
Email	ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person	Koichi Kaikita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Cardiovascular medicine
Address	Honjo 1-1-1, Chuo-ku, Kumamoto, Japan
TEL	096-373-5175
Homepage URL
Email	kaikitak@kumamoto-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Kumamoto Hospital Fukuoka Tokusyukai Medical Center
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	熊本大学医学部附属病院（熊本県） 熊本赤十字病院（熊本県） 福岡徳洲会病院（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 22 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2017 Year 03 Month 27 Day
Date of closure to data entry	2017 Year 03 Month 27 Day
Date trial data considered complete	2017 Year 03 Month 27 Day
Date analysis concluded

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

Management information
Registered date	2012 Year 06 Month 12 Day
Last modified on	2017 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009423