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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017131
Receipt No. R000019868
Scientific Title Regulated Optical coherence tomography Follow-ups for Thrombus Evaluation-01 (ROUTE-01) study
Date of disclosure of the study information 2015/04/14
Last modified on 2019/05/07

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Basic information
Public title Regulated Optical coherence tomography Follow-ups for Thrombus Evaluation-01 (ROUTE-01) study
Acronym ROUTE-01 study
Scientific Title Regulated Optical coherence tomography Follow-ups for Thrombus Evaluation-01 (ROUTE-01) study
Scientific Title:Acronym ROUTE-01 study
Region
Japan

Condition
Condition patients with coronary artery disease referred for PCI under treatment with prasugrel 3.75mg/day
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the association among the frequency of in-stent thrombus, phenotype of CYP2C19 and the ability of platelet aggregation.
To assess the impact of phenotype of CYP2C19 and ability of platelet aggregation on major adverse cardiovascular events and bleeding complications.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the frequency of in-stent thrombus assessed by follow-up OCT 9 months after stent implantation
Key secondary outcomes NIT and % of uncovered stent struts assessed by follow-up OCT 9 months after stent implantation
Major adverse cardiovascular and cerebral events (MACCE)
Bleeding complications

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Optical coherence tomography (OCT) was performed for the stented vessel at index PCI and 9 months after stent implantation under prescription of prasugrel
Interventions/Control_2
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
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with coronary artery disease (including ACS) referred for PCI under treatment with prasugrel 3.75mg/day
Key exclusion criteria 1.patient treated with warfarin or novel oral anticoagulants (NOAC)
2.patient treated with other antiplatelet therapy
3.planning an invasive treatment with high bleeding risk
4.contraindication of aspirin or prasugrel
Target sample size 250

Research contact person
Last name of lead principal investigator
1st name Kenichi
Middle name
Last name Hirata
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code 6500017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL 078-382-5111
Email hiratak@med.kobe-u.ac.jp

Public contact
1st name of contact person
1st name Toshiro
Middle name
Last name Shinke
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code 6500017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL 078-382-5111
Homepage URL
Email shinke@med-showa-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe University Hospital Clinical and Translational Research Center
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
Tel 078-382-6669
Email chiken@med.kobe-u.ac.jp

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
2015 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 250
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 Main results already published
Date of protocol fixation
2015 Year 03 Month 19 Day
Date of IRB
2015 Year 06 Month 12 Day
Anticipated trial start date
2015 Year 10 Month 17 Day
Last follow-up date
2018 Year 12 Month 25 Day
Date of closure to data entry
2019 Year 03 Month 14 Day
Date trial data considered complete
2019 Year 03 Month 27 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information 1.OCT analysis before and after PCI
2.antiplatelet aggregation test and examination of phenotype of CYP2C19 at PCI procedure
3.OCT analysis and antiplatelet aggregation test 9 months after stent implantation
4.clinical follow-up (MACCE and bleeding complication) from stent implantation and 15 months after stent implantation

Management information
Registered date
2015 Year 04 Month 14 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019868

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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