UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026672 |
|---|---|
| Receipt number | R000030629 |
| Scientific Title | Effect of cilostazol on endothelial function and platelet function in patients receiving clopidogrel |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2024/03/28 17:52:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of cilostazol on endothelial function and platelet function in patients receiving clopidogrel
Acronym
CSPS.com substudy in TWMU
Scientific Title
Effect of cilostazol on endothelial function and platelet function in patients receiving clopidogrel
Scientific Title:Acronym
CSPS.com substudy in TWMU
Region
| Japan |
Condition
Condition
Non-cardiogenic brain infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of cilostazol on endothelial function and platelet function in ischemic stroke patients receiving clopidogrel
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Flow-mediated dilatation (% FMD)
2. Thrombus formation and platelet aggregability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cilostazol 200 mg per day
Interventions/Control_2
Non cilostazol
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non-cardiogenic brain infarction within 6 months receiving clopidogrel under consideration of CSPS.com enrollment
Key exclusion criteria
Patients who take aspirin or oral anti-coagulant
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kitagawa |
Organization
Tokyo Women's Medical Univeristy
Division name
Department of Neurology
Zip code
162-8666
Address
8-1 Kawada-cho Shinjuku-ku Tokyo 1628666
TEL
0333538111
kkitagawa@nij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Kitagawa |
Organization
Tokyo Women's Medical University
Division name
Department of Neurology
Zip code
1628666
Address
Shinjuku-ku
TEL
0333538111
Homepage URL
kitagawa.kazuo@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical Univeristy
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical Univeristy
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
Clinical Research Center, Tokyo Women's Medical University Hospital
Address
Kawada-cho 8-1
Tel
0333538111
kitagawa.kazuo@twmu.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
東京女子医科大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
J Neurol Sci. 2022 Aug 15;439:120318. doi: 10.1016/j.jns.2022.120318
Publication of results
Published
Result
URL related to results and publications
J Neurol Sci. 2022 Aug 15;439:120318. doi: 10.1016/j.jns.2022.120318
Number of participants that the trial has enrolled
29
Results
FMD in brachial artery was similar between at baseline and after 6 months in the control group. In contrast, FMD significantly increased from baseline to 7 after 6 months in the cilostazol group ( p = 0.019).
Results date posted
| 2024 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was conducted at the Tokyo Women's Medical University Hospital from December 2014 to March 2017. We selected the patients taking clopidogrel enrolled in the CSPS.com study in our hospital. They were randomly assigned to two group; cilostazol plus clopidogrel (CIL group), and clopidogrel without cilostazol (control group) centrally through a web-based registration system. The eligibility criteria of CSPS.com study was a non-cardioembolic ischemic stroke between 8 days and 180 days since stroke onset. They were required to take either aspirin or clopidogrel alone and meet at least one of the following three criteria: at least 50% stenosis of a major intracranial artery, at least 50% stenosis of an extracranial artery, and two or more vascular risk factors.
Participant flow
Endothelial function was assessed by measuring FMD of the brachial artery in response to hyperemia according to methods previously described. FMD was shown to be related to several vascular risk factors such as blood pressure level and a significant predictor of cardiovascular events. The subjects were studied in a quiet and temperature-controlled room, from 9 to 11 AM. The extent of FMD in the brachial artery was measured by ultrasonography using a high-resolution ultrasound system equipped with a 10-MHz linear array transducer. The subjects were placed in the sitting position with their right arms in a comfortable position for the examination. A segment with clear anterior and posterior intimal interfaces between the lumen and vessel wall was selected for continuous 2D grayscale imaging at rest. Thereafter, arterial occlusion was created by forearm-cuff inflation to at least 50 mmHg above systolic blood pressure for 5 min before release. After deflation of the cuff, the diastolic diameter of the brachial artery was semi-automatically recorded continuously for 3 min. FMD is defined as the maximal percent change in brachial artery diameter after reactive hyperemia compared with the baseline. FMD was performed at baseline and at 6 months after randomization.
Adverse events
None
Outcome measures
FMD
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
