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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007367
Receipt No. R000008674
Scientific Title Effects of dual antiplatelet therapy on cerebral microbleeds in patients with coronary artery disease
Date of disclosure of the study information 2012/02/27
Last modified on 2021/03/01

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Basic information
Public title Effects of dual antiplatelet therapy on cerebral microbleeds in patients with coronary artery disease
Acronym Effects of DAPT on cerebral microbleeds in CAD patients
Scientific Title Effects of dual antiplatelet therapy on cerebral microbleeds in patients with coronary artery disease
Scientific Title:Acronym Effects of DAPT on cerebral microbleeds in CAD patients
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the changes in cerebral microbleeds (CMBs) between coronary artery disease (CAD) patients with dual antiplatelet therapy (DAPT) and those with aspirin monotherapy (SAPT) using brain magnetic resonance imaging
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Localization and number of new CMBs after 8-month treatment
Key secondary outcomes Location and number of new lesions of cerebral infarction and cerebral bleeding
White matter hyperintensity
Carotid/intracranial arterial lesions

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Angiographically proven CAD patients who undergo DAPT (e.g. patients undergoing drug-eluting stent implantation)(DAPT group) and age-, gender-, and coronary lesion severity-matched patients undergoing aspirin monotherapy (SAPT group)
Key exclusion criteria Acute coronary syndrome
Contraindication for MRI
Contraindication for aspirin and/or clopidogrel
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Fukuda
Organization Kurume University School of Medicine
Division name Cardio-vascular Medicine
Zip code 830-0011
Address 67 Asahimachi, Kurume, Fukuoka 830-0011
TEL +81-942-31-7562
Email kfuku@kurume.ktarn.or.jp

Public contact
Name of contact person
1st name Yoshiko
Middle name
Last name Iwamoto
Organization Kurume University School of Medicine
Division name Cardio-vascular Medicine
Zip code 830-0011
Address 67 Asahimachi, Kurume, Fukuoka 830-0011
TEL +81-942-31-7562
Homepage URL
Email iwamoto_yoshiko@med.kurume-u.ac.jp

Sponsor
Institute Cardio-vascular Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization Cardio-vascular Medicine, Kurume University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Center, Kurume University Hospital
Address 67 Asahimachi, Kurume, Fukuoka 830-0011, Japan
Tel +81-942-65-3749
Email :kcrc_jimu@kurume-u.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 久留米大学病院(福岡県)久留米大学医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 27 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000008674
Publication of results Partially published

Result
URL related to results and publications Int J Cardiovasc Res 2017, 6:6 DOI: 10.4172/2324-8602.1000337
Number of participants that the trial has enrolled 14
Results Baseline MRI revealed CMBs in two patients (14%). New CMBs were detected by follow-up MRI in two other patients (14%). CMB-positive patients had a greater number of coronary artery lesions (p=0.04) and a tendency to have a higher SYNTAX score at baseline (p=0.06) than CMB-negative patients.
Results date posted
2021 Year 03 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics CAD patients who underwent antiplatelet therapy (DAPT in 13 patients) and had no history of symptomatic stroke.
Participant flow Brain MRI was performed at baseline and after 8-month follow-up.
Adverse events not present
Outcome measures cerebral microbleeds on brain MRI
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 02 Month 16 Day
Date of IRB
2012 Year 02 Month 16 Day
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 15 Day
Date trial data considered complete
2018 Year 04 Month 01 Day
Date analysis concluded
2022 Year 09 Month 01 Day

Other
Other related information Under data analysis

Management information
Registered date
2012 Year 02 Month 23 Day
Last modified on
2021 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008674

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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