UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007367 |
|---|---|
| Receipt number | 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 | 2024/03/26 14:54:24 |
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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
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
iwamoto_yoshiko@med.kurume-u.ac.jp
Sponsor or person
Institute
Cardio-vascular Medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
: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
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.
Management information
Registered date
| 2012 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008674
