UMIN-CTR Clinical Trial

Public title

Investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodREsorbable-polymer drug-eluting stent

Acronym

REIWA registry

Scientific Title

Investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodREsorbable-polymer drug-eluting stent: A multicenter, prospective registry from IWAte medical university affiliated hospitals

Scientific Title:Acronym

REIWA registry

Region

Japan

Condition

coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate one year clinical outcomes in patients with one month dual antiplatelet(DAPT) therapy after implantation of bioresorbable polymer based drug-eluting stents

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Composite endpointof cardiovascular death, stroke, stent thrombosis, clinically significant bleeding

Key secondary outcomes

Cardiovascular death/ MI/ stroke/ definite ST at 12 months

Major bleeding (TIMI Major/ Minor) at 12 months

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients with successful BP-DES implantation as well as no major adverse events (death, new onset AMI, stroke, major bleeding) during hospitalization
2) Patients who can continue DAPT of aspirin and P2Y12 receptor antagonist
3) Patients with completed informed consent

Key exclusion criteria

1) patients requiring oral anticoagulant
2) patients with previous history of stent thrombosis
3)patients treated with any stents except BP-DES
4) patients known to have intolerance of P2Y12 receptor antagonist
5) patients requiring other antiplatelet agents except aspirin and P2Y12 inhibitor
6) patients who have cancer with life expectancy shorter than 2 years
7) pregnant or antcipated pregnant woman
8) patients implanted bioresorbable scaffold within 3 years

Target sample size

1200

Name of lead principal investigator

1st name	Yoshihiro
Middle name
Last name	Morino

Organization

Iwate Medical University Hospital

Division name

Division of Cardiology, Department of Internal Medicine

Zip code

020-3695

Address

2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate

TEL

+81-19-613-7111

Email

ymorino@iwate-med.ac.jp

Name of contact person

1st name	Yumiko
Middle name
Last name	Okuyama

Organization

Iwate Medical University Hospital

Division name

Division of Cardiology, Department of Internal Medicine

Zip code

020-3695

Address

2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate

TEL

+81-19-613-7111

Homepage URL

Email

yokuyama@iwate-med.ac.jp

Institute

Division of Cardiology, Department of Internal Medicine, Iwate Medical University

Institute

Department

Personal name

Organization

Division of Cardiology, Department of Internal Medicine, Iwate Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Iwate Medial University School of Medicine

Address

2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate

Tel

+81-19-613-7111

Email

hiroaki.kawamori@j.iwate-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

07

Month

09

Day

Date of IRB

2019

Year

07

Month

01

Day

Anticipated trial start date

2019

Year

07

Month

10

Day

Last follow-up date

2022

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patients who met registration criteria and received bioresorbable polymer-based drug-eluting stent (either Synergy, Ultimaster, Orsiro), as well signed complete informed consent are enrolled to study (within 30 plus minus 3days after stent placement). Standard DAPT regimen (aspirin and thienopyridine) for 1 month followed by thienopyridine. Clinical outcomes are surveyed at 12 plus minus 1 month.

Planned number of study patients
1200 patients, at most 400 patients can be enrolled for each stent, at Iwate medical university 10 affiliated hospitals.

Primary endpoint is 12 month composite endpoint of cardiovascular death, MI, stroke, stent thrombosis, and major bleeding.

Registered date

2019

Year

07

Month

10

Day

Last modified on

2023

Year

08

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042548