UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014882 |
|---|---|
| Receipt number | R000017307 |
| Scientific Title | A Prospective, Single-center Investigation of the Impact of Antithrombotic Drugs and Cerebral Microbleeds on Cerebral Outcomes in Patients with Coronary Artery Stents |
| Date of disclosure of the study information | 2014/08/18 |
| Last modified on | 2022/09/12 06:02:51 |
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Basic information
Public title
A Prospective, Single-center Investigation of the Impact of Antithrombotic Drugs and Cerebral Microbleeds on Cerebral Outcomes in Patients with Coronary Artery Stents
Acronym
Antithrombotic Drugs and Cerebral Microbleeds in Coronary Artery Disease
Scientific Title
A Prospective, Single-center Investigation of the Impact of Antithrombotic Drugs and Cerebral Microbleeds on Cerebral Outcomes in Patients with Coronary Artery Stents
Scientific Title:Acronym
Antithrombotic Drugs and Cerebral Microbleeds in Coronary Artery Disease
Region
| Japan |
Condition
Condition
Ischemic heart disease treated by percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of antithrombotic drugs and cerebral microbleeds on cerebral outcomes in patients with coronary artery stents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral event including cerebral infarction, cerebral hemorrhage, subdural hematoma, epidural hematoma, subarachnoid hemorrhage and transient ischemic attacks after one year
Key secondary outcomes
After one year,
1. cardiac or non-cardiac death
2. cardiac event including sudden death and coronary revascularizations
3. major bleedings by the ISTH criteria (international Society of Thrombosis and Hemostasis)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Ischemic heart disease with coronary artery stents
2. Performed Brain magnetic resonance imaging in 1 month around the day when coronary stents were implanted
3. Dual antiplatelet therapy for 1 year
4. Age above 20
Key exclusion criteria
1. Claustrophobia
2. Inadequate to be enrolled
Target sample size
535
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Satoshi |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibe-shimmachi, Suita, Osaka
TEL
06-6170-1070
yasuda.satoshi.hp@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Masashi |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1, Kishibe-shimmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
fujinom@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center, Division of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, National Cerebral and Cardiovascular Center
Address
6-1, Kishibe-shimmachi, Suita, Osaka
Tel
06-6170-1070
plandiv@ml.ncvc.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
| 2014 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
End of Publication
Publication of results
Unpublished
Result
URL related to results and publications
not yet published
Number of participants that the trial has enrolled
329
Results
The prevalence of intracerebral microbleeds (CMBs) was 33% (n=109), with a mean number of CMBs of 2.9+-3.6 (median 2, quartile range 1-3), of which 16 (15%) were multi-CMBs (>4). ICH occurred in 1 of 4 CMBs (1.1%), with no significant difference in ICH prevalence among the 3 groups. CMB was associated with all-cause mortality (non-CMB vs. CMB<5 vs. CMB>4, 3.6% vs. 12.0% vs. 6.3%, P=0.022).
Results date posted
| 2022 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ischemic heart disease
Participant flow
Observational study
Adverse events
None
Outcome measures
Intracerebral hemorrhage, all-cause death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
ID, patient characteritics
Management information
Registered date
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017307
