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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028967
Receipt No. 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

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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
Email 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
Email shinya@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Department of Cardiovascular Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026586

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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