UMIN-CTR Clinical Trial

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
Email	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
Email	fujinom@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center, Division of Cardiovascular Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017307