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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005240
Receipt No. R000001124
Scientific Title Optimal dose of Cropidogrel to prevent stent thrombosis after drug-eluting stent implantation in Japanese : a randomised control trial
Date of disclosure of the study information 2011/03/11
Last modified on 2015/05/05

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Basic information
Public title Optimal dose of Cropidogrel to prevent stent thrombosis after drug-eluting stent implantation in Japanese : a randomised control trial
Acronym Optimal dose of Cropidogrel to prevent stent thrombosis after drug-eluting stent implantation in Japanese : a randomised control trial
Scientific Title Optimal dose of Cropidogrel to prevent stent thrombosis after drug-eluting stent implantation in Japanese : a randomised control trial
Scientific Title:Acronym Optimal dose of Cropidogrel to prevent stent thrombosis after drug-eluting stent implantation in Japanese : a randomised control trial
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Optimal dose of Cropidogrel to prevent stent thrombosis after drug-eluting stent impantation in Japanese
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MACE (major adverse cardiac event), side effect of clopidogrel, bleedin event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 100 patients who underwent coronary intervention and deployed drug-eluting stent at Chiba university hospital since November 2007 are randomly assigned to clopidogrel 75mg/day group. After at least 12 months period, we evaluate stent thrombosis, side effect of clopidogrel and bleeding event.
Interventions/Control_2 100 patients who underwent coronary intervention and deployed drug-eluting stent at Chiba university hospital since November 2007 are randomly assigned to clopidogrel 50mg/day group. After at least 12 months period, we evaluate stent thrombosis, side effect of clopidogrel and bleeding event.
Interventions/Control_3
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent drug-eluting stent implantation and not meet the exclusion criteria
Key exclusion criteria 1 Acute Myocardial Infarction and coronary disease associate with thrombosis
2 complicated active bleeding , diathesis of thrombosis
3 neutropenia
4 thrombocytepenia
5 sever liver dysfunction
6 chronic renal failure
7 sever uncontroled hypertension
8 allergy for clopidgrel and/or aspirin
9 shock stete sta
10 chronic cardiad failure
11 body weight<40 kg
12 pregnancy
13 comorbid malignancy tumor
14 age > 80
15 poor expectation for prognosis by any cause
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Ohkubo
Organization Department of Cardiovascular Science and Medicine Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan
TEL 043-222-7171
Email kenji_ookubo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Ohkubo
Organization Department of Cardiovascular Science and Medicine Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan
TEL 043-222-7171
Homepage URL
Email kenji_ookubo@yahoo.co.jp

Sponsor
Institute Department of Cardiovascular Science and Medicine Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular Science and Medicine Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2011 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2007 Year 11 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
2011 Year 03 Month 11 Day
Last modified on
2015 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001124

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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