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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003898
Receipt No. 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

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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
Email

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
Email tnoguchi@hsp.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004685

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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