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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027356
Receipt No. R000031122
Scientific Title Study of Real World Anticoagulation and Antiplatelet Practice in Patients with Acute Coronary Syndrome Complicated with Atrial fibrillation
Date of disclosure of the study information 2017/05/16
Last modified on 2017/05/19

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Basic information
Public title Study of Real World Anticoagulation and Antiplatelet Practice in Patients with Acute Coronary Syndrome Complicated with Atrial fibrillation
Acronym STAR-ACS
Scientific Title Study of Real World Anticoagulation and Antiplatelet Practice in Patients with Acute Coronary Syndrome Complicated with Atrial fibrillation
Scientific Title:Acronym STAR-ACS
Region
Japan

Condition
Condition Atrial fibrillation combined acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There are various patterns of use of triple anti-thrombotic therapy (DAPT+warfarin,DAPT+NOAC), and the outcomes were difference according the variation of using drugs. As possible, this study will prove that NOAC have a definite place in the treatment of patients with AF, where they are at least as effective,if not superior to warfarin.
The primary objectives of this study were to (1) explore the actual antithrombotic therapy with AF complicating ACS, the patterns of use of triple therapy (DAPT+warfarin, DAPT+NOAC), and the outcomes among patients who were use of NOAC versus not NOAC, (2) describe the use of antithrombotic therapy according to the CHADS2 risk score, and (3) assess the relationship between actual antithrombotic regimen and hemorrhagic and thrombotic events in patients with both ACS and AF, a very high risk population in Japan today.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes #1 Major Bleeding according to International Soiety of Thrombosis and Hemostasis (ISTH)
#2 MACCE (major adverse cardio-cerebral event): composite endpoint of death associated withACS/storoke and other cardiovascular (CV) deaths, non-fatal ACS and non-fatal stroke,and stent thrombosis
Key secondary outcomes 1) Death due to hemorrhage,
2) Cardiac death, CV death (cause of mortality)
3) Non-CV death (cause of death;final clinical diagnosis of death)
4) Bleeding

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
999 years-old >=
Gender Male and Female
Key inclusion criteria Patients with ACS meeting following criteria who are admitted to hospitals will be enrolled in this registry, if patients are confirmed to have atrial fibrillation until discharge and provide written informedconsent.
Patients will be consecutively registered at study sites.
Key exclusion criteria 1) ACS caused by surgery, trauma, or coronary rebascularization (PCI or CABG)
2) Patients under 20years of age
3) Transient af after the onset of ACS is excluded
4) Patients considered inappropriatc for study participation by attending physician
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Daida
Organization Juntendo University graduate school
Division name Department of Cardiovascular Medicine, Graduate School of Medicine
Zip code
Address Hongo, Bunkyo-ku, Tokyo 3-1-3
TEL 03-3813-3111
Email juntencrc@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyauchi Katumi
Organization Juntendo University
Division name Department of Cardiovascular Medicine, Graduate School of Medicine
Zip code
Address Hongo, Bunkyo-ku, Tokyo 3-1-3
TEL 03-3813-3111
Homepage URL
Email juntencrc@juntendo.ac.jp

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

Funding Source
Organization Bristol-Myers Squibb Co., Ltd.
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
Address
Tel
Email

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 05 Month 16 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031122

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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