UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017131 |
|---|---|
| Receipt number | 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 10:49:55 |
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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
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
hiratak@med.kobe-u.ac.jp
Public contact
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
shinke@med-showa-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019868
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
