UMIN-CTR Clinical Trial

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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