UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008151 |
|---|---|
| Receipt number | 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 16:58:44 |
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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
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
kaikitak@kumamoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009423
