UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028967 |
|---|---|
| Receipt number | R000026586 |
| Scientific Title | Comparison of the Healing response of Durable polymer versus Bioresorbable polymer DES in patients with acute coronary syndrome |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/03/09 21:25:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of the Healing response of Durable polymer versus Bioresorbable polymer DES in patients with acute coronary syndrome
Acronym
HR-ACS study
Scientific Title
Comparison of the Healing response of Durable polymer versus Bioresorbable polymer DES in patients with acute coronary syndrome
Scientific Title:Acronym
HR-ACS study
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To asses the healing responce of two different DES groups such as durable polymer DES and bioressorbable polymer DES on the mal-apposition
and uncovered strut by OCT analyses during 6months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the healing response by the OCT findings between Synergy and XIENCE after 6 monts in patients with ACS.
Key secondary outcomes
In staged PCI case, OCT findings also compared between two groups after 1 month of ACS-onset.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Synergy group
Interventions/Control_2
XIENCE group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute coronary syndrome
more than 20 years old
Informed concent
Key exclusion criteria
less than 20 years old
Indication of CABG
Patients need anti-cancer drug
Patients need non cardiac surgery within 6M
Cardiogenick shock and ADHF
Patients with severe kidney D.
Other reasons (not suitable for this study)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Okazaki |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0333672908
shinya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Okazaki |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0333672908
Homepage URL
shinya@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
Department of Cardiojogy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University, GCP center
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2017 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026586
