UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003898 |
|---|---|
| Receipt number | R000004685 |
| Scientific Title | A randomized study of the influence of proton pump inhibitors on antiplatelet effect by Clopidogrel based on CYP2C19 genotypes |
| Date of disclosure of the study information | 2010/07/20 |
| Last modified on | 2010/07/20 11:05:09 |
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Basic information
Public title
A randomized study of the influence of proton pump inhibitors on antiplatelet effect by Clopidogrel based on CYP2C19 genotypes
Acronym
CYP2C19, Clopidgrel and Proton Pump Inhibitor Estimation study(CYCLON study)
Scientific Title
A randomized study of the influence of proton pump inhibitors on antiplatelet effect by Clopidogrel based on CYP2C19 genotypes
Scientific Title:Acronym
CYP2C19, Clopidgrel and Proton Pump Inhibitor Estimation study(CYCLON study)
Region
| Japan |
Condition
Condition
Angina pectoris and myocardial infarction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We hypothesized that proton pomp inhibitors may affect antiplatelet effect by clopidogrel based on CYP2C19 genotypes in patients with coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inhibitory effect of anti-platelet aggregation estimated by phosphorytation of VASP after administration of clopidgrel and proton pump inhibitors
Key secondary outcomes
relationship between CYP2C19 genotypes and the effect of proton pump inhibitors on anti-platelet aggregation by clopidgrel
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Study patients are randomized into three groups according to proton pump inhibitors administration.
a) Rabeprazole 10mg
Interventions/Control_2
b) Lansoprazole 30mg
Interventions/Control_3
c) Omeprazole 20mg
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient with angina pectoris or myocardial infarction, who underwent de novo coronary stent implantation
Key exclusion criteria
1) the patient of severe liver disease
2) the patient of severe renal disease
3) the patient of congenital heart disease
4) the patient of myocardial infarction within 3 months from onset or of severe cardiac function
5) the patient of endocrine disease
6) the patient of malignant or inflammatory disease
7) the patient of severe respiratory disease including idiopathic pulmonary artery hypertension
8) the patient of impaired activities of daily living by neurological or orthopedic disease
9) the patient of severe hypertension
10) the patient who taking corticosteroid or immunosuppressive drug
11) the patient of type 1 diabetes mellitus
12) the patient pregnant or probable of pregnancy
13) the catecholamine injected patient
14) the patient of symptomatic hypotension
15) the patient with left ventricular outflow tract obstruction, hypertrophic obstructive cardiomyopthy or aortic stenosis, effecting hemodynamics significantly
16) the patient who is judged inappropriate for any reason by doctor
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nonogi Hiroshi |
Organization
National Cerebral and Cardiovascular center
Division name
Division of cardiology, Department of Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noguchi Teruo |
Organization
National Cerebral and Cardiovascular center
Division name
Division of cardiology, Department of Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
tnoguchi@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 09 | Day |
Last modified on
| 2010 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004685
