UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026694 |
|---|---|
| Receipt number | R000030644 |
| Scientific Title | Bleeding and thrombotic risk evaluation in patients with atrial fibrillation under coronary intervention |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2021/01/01 19:23:02 |
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Basic information
Public title
Bleeding and thrombotic risk evaluation
in patients with atrial fibrillation under coronary intervention
Acronym
BIWACO study
Scientific Title
Bleeding and thrombotic risk evaluation
in patients with atrial fibrillation under coronary intervention
Scientific Title:Acronym
BIWACO study
Region
| Japan |
Condition
Condition
atrial fibrillation and ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analysis of bleeding risks under anticoagulation therapy using three bleeding scores in atraila fibrillation patients with coronary stent therapy in Shiga prefecture
Basic objectives2
Others
Basic objectives -Others
risk scoring of bleeding in recruited patients and follow-up observation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of bleeding and systemic thrombosis events using PARIS risk score,DAPT score, ORBIT score and PRECISE-DAPT score
Key secondary outcomes
all cause of death, cardiovascular death, hemorrhagic events, hospitalization for heart faliure, myocardial infarction, cerebral infarction and coronary revasculization
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.patients with atraial fibrillation documented with ECG
2.patientes received PCI therapy for coronary arterial stenosis
3.age; 20~95
4.More than one Risk factor including hpertension, DM and history of stoke and or Heart failure,
Key exclusion criteria
cardiogenic shock or hypotension,
vulnerable ischemic stroke and bleeding,
current heart failure hospitalization,
a history of stent thrombosis,
coexisting active tumor,
poorly controlled hypertension,
severe infections,
severe liver injury
pregnant women.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Atsuyuki |
| Middle name | |
| Last name | Wada |
Organization
Kusatsu General Hospital
Division name
Division of Cardiology
Zip code
525-8585
Address
1660 Yabase, Kusatsu, Shiga
TEL
077-563-8866
wada@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsuyuki |
| Middle name | |
| Last name | Wada |
Organization
Kusatu General Hospital
Division name
Division of Cardiology
Zip code
525-8585
Address
1660 Yabase, Kusatsu, Shiga
TEL
077-563-8866
Homepage URL
wada@belle.shiga-med.ac.jp
Sponsor or person
Institute
Kusatu General Hospital
Division of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Kusatu General Hospital
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
Kusatsu General Hospital
Address
1660 Yabase, Kusatsu, Shiga, Japan
Tel
81-77-563-8866
wada@belle.shiga-med.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
草津総合病院、湖東記念病院、甲賀病院、長浜赤十字病院、地域医療機能推進機構滋賀病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
The BIWACO study was a prospective, multicenter, observational registry endeavor designed to provide
Publication of results
Partially published
Result
URL related to results and publications
20201231
Number of participants that the trial has enrolled
7837
Results
Over 3 years, 37 patients developed NACE, including 10 (5.3% of all patients) who died and two with thrombotic events; the remaining 25 (13.3%) experienced bleeding events as shown in Figure 3. Causes of death of the 10 deceased patients were cardiac (n=3), stroke (n=4), systemic thrombosis (n=1), and non-cardiovascular (n=2). Major bleeding was observed in 25 patients including one intracranial hemorrhage and 13 patients with severe gastrointestinal bleeding.
Results date posted
| 2020 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics of the patients.
Characteristics
Patient number 188
Age, y 74.2
Male, n (%) 139 (73.9)
BMI, kg/m2 23.1
Current smoker, n (%) 52 (27.7)
Hypertension, n (%) 160 (85.1)
Diabetes mellitus, n (%) 67 (35.8)
Permanent AF, n (%) 86 (46.0)
HFrEF, n (%) 28 (14.9)
BNP over200, n (%) 70 (37.2)
eGFR under 60, n (%) 112 (59.6)
ESRD on hemodialysis, n (%) 6 (3.2)
Anemia, n (%) 85 (45.2)
ACS, n (%) 53 (28.2)
Stent diameter, mm 3.04
Stent length, mm 24
Prior myocardial infarction, n (%) 34 (18.1)
Prior PCI, n (%) 70 (37.2)
Prior CABG, n (%) 12 (6.4)
Prior ischemic stroke, n (%) 33 (17.6)
Prior major bleeding, n (%) 16 (8.6)
Prior hemorrhagic stroke, n (%) 3 (1.6)
Participant flow
A total of 7837 consecutive patients who received PCI with DES implantation was enrolled in the BIWACO study. The first registration begun from April 1st, 2014. Of these, only 219 (2.8%) had a medical history of AF at the time of hospitalization. We excluded 31 patients because they were treated by balloon angioplasty alone, leaving 188 patients in this analysis.
Adverse events
Over 3 years, 37 patients developed NACE, including 10 (5.3% of all patients) who died and two with thrombotic events; the remaining 25 (13.3%) experienced bleeding events as shown. Causes of death of the 10 deceased patients were cardiac (n=3), stroke (n=4), systemic thrombosis (n=1), and non-cardiovascular (n=2). Major bleeding was observed in 25 patients including one intracranial hemorrhage and 13 patients with severe gastrointestinal bleeding.
Outcome measures
The primary endpoints for this study were composite endpoints of NACE defined as the composite of all-cause death, thrombotic and bleeding events within four years of the PCI procedure. Cardiac death included sudden death, progressive HF, and fatal myocardial infarction. HF was diagnosed if the patient had a history of hospitalization for HF or if the left ventricular ejection fraction was <40%. Chronic kidney disease (CKD) was diagnosed if there was persistent proteinuria or if the estimated glomerular filtration rate (eGFR) was <60 mL/min/1.73 m2. Bleeding was defined as the occurrence of Bleeding Academic Research Consortium type 2, 3 or 5 and complications thereof were defined as the requirement for blood transfusion or prolonged hospitalization owing to subcutaneous hematoma, gastrointestinal bleeding, or intracranial bleeding (14). Thrombotic events were defined as the sudden onset of a focal neurologic deficit in a location consistent with the territory of a major cerebral artery and an acute vascular occlusion of a coronary and peripheral arteries confirmed by angiography. With respect to specific bleeding risk prediction, we compared the predictive performance of the BIWACO score to those of four previously existing bleeding scores, namely, PARIS , ORBIT , HAS-BLED and PRECISE-DAPT.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | 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 | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Evaluation of bleeding risks of both anticoagulation and antiplatelet therapy in atrila fibrillation patients with PCI therapy in Shiga prefecture.
The first registration begun from 1st, April, 2014 (the registration number 2014-001).
Management information
Registered date
| 2017 | Year | 03 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030644
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