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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name