UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020452
Receipt number R000023601
Scientific Title Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial
Date of disclosure of the study information 2016/01/18
Last modified on 2020/01/08 12:53:56

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Basic information

Public title

Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial

Acronym

Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial

Scientific Title

Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial

Scientific Title:Acronym

Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial

Region

Japan


Condition

Condition

Coronary heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine if the aggressive statin treatment is more effective to prevent very-late DES failure than the standard statin treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Very-late DES failure (cardiac death or TLR) at 5 years

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

The aggressive statin treatment, targeted at LDL-C < 70mg/dl, for 5 years.

Interventions/Control_2

The standard statin treatment, targeted at LDL-C < 100mg/dl, for 5 years

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 who received PCI with DES.

Key exclusion criteria

None.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Yasunori
Middle name
Last name Ueda

Organization

National Hospital Organization Osaka National Hospital

Division name

Cardiovascular Division

Zip code

540-0006

Address

2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN

TEL

+81-6-6942-1331

Email

ueda.yasunori.ju@mail.hosp.go.jp


Public contact

Name of contact person

1st name Yasunori
Middle name
Last name Ueda

Organization

National Hospital Organization Osaka National Hospital

Division name

Cardiovascular Division

Zip code

540-0006

Address

2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN

TEL

+81-6-6942-1331

Homepage URL


Email

ueda.yasunori.ju@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Osaka National Hospital

Institute

Department

Personal name



Funding Source

Organization

Abbott Vascular Japan

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

National Hospital Organization Osaka National Hospital

Address

2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN

Tel

+81-6-6942-1331

Email

408-chiken@mail.hosp.go.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

2016 Year 01 Month 18 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

Enrolling by invitation

Date of protocol fixation

2015 Year 12 Month 18 Day

Date of IRB

2015 Year 09 Month 29 Day

Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date

2025 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 06 Day

Last modified on

2020 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name