UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027356 |
|---|---|
| Receipt number | 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 | 2023/05/22 09:55:33 |
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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
460
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Daida |
Organization
Juntendo University graduate school
Division name
Department of Cardiovascular Medicine, Graduate School of Medicine
Zip code
113-8431
Address
Hongo, Bunkyo-ku, Tokyo 3-1-3
TEL
03-3813-3111
juntencrc@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Katumi |
| Middle name | |
| Last name | Miyauchi |
Organization
Juntendo University
Division name
Department of Cardiovascular Medicine, Graduate School of Medicine
Zip code
113-8431
Address
Hongo, Bunkyo-ku, Tokyo 3-1-3
TEL
03-3813-3111
Homepage URL
juntencrc@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Department of Cardiovascular Medicine, Graduate School of Medicine
Institute
Department
Personal name
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
Hospital Ethics Committee Juntendo University Hospital
Address
Hongo, Bunkyo-ku, Tokyo 3-1-3
Tel
03-3813-3111
jun-rinri@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 | 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
460
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
statistics analyze the operation
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 | 12 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 26 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 09 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 22 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031122
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