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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008151
Receipt No. R000009423
Scientific Title Controlled Anti-platelet medical therapy based on rapid CYP2C19 gene evaluation in Acute myocardial infarction
Date of disclosure of the study information 2012/06/12
Last modified on 2017/03/27

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Basic information
Public title Controlled Anti-platelet medical therapy based on rapid CYP2C19 gene evaluation in Acute myocardial infarction
Acronym CALDERA-GENE STUDY
Scientific Title Controlled Anti-platelet medical therapy based on rapid CYP2C19 gene evaluation in Acute myocardial infarction
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Cardiovascular medicine
Zip code
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
1st name
Middle name
Last name Koichi Kaikita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Cardiovascular medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 05 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009423

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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