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

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 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

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

Value
https://center6.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