UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013864 |
|---|---|
| Receipt number | R000016172 |
| Scientific Title | Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patients |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2015/03/14 14:30:11 |
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Basic information
Public title
Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patients
Acronym
Cilostazol and EPA stroke prevention study (CESP study)
Scientific Title
Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patients
Scientific Title:Acronym
Cilostazol and EPA stroke prevention study (CESP study)
Region
| Japan |
Condition
Condition
Non-cardioembolic cerebral infarction
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol and dual antidyslipidemia therapy (DADT) including eicosapentaenoic acid and statin in comparison with antiplatelet monotherapy (excluding cilostazol) and statin monotherapy for secondary prevention of acute ischemic stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours
Key secondary outcomes
Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)]
IS or transient ischemic attack (TIA)
ICH or SAH
Death from any cause
Stroke (IS, ICH, SAH), myocardial infarction (MI), or vascular events
All vascular events: stroke, MI, and other vascular events
Adverse events and adverse drug reactions
Severe or life-threatening hemorrhage (GUSTO Criteria)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antiplatelet monotherapy (excluding cilostazol) and statin monotherapy
Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administrated once daily. Statin (atorvastatin 10mg, pitavastatin 2mg or rosuvastatin 2.5mg) will be orally administered once daily. The treatment will begin within 7 days from the onset of noncardioembolic stroke.
Interventions/Control_2
Experimental: DAPT and DADT
Dual antiplatelet therapy including cilostazol and dual antidyslipidemia therapy including eicosapentaenoic acid and statin
Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg). Eicosapentaenoic acid (900mg twice daily) will be orally administered in combination with statin (atorvastatin 10mg, pitavastatin 2mg or rosuvastatin 2.5mg once daily).
The treatment will begin within 7 days from the onset of noncardioembolic stroke.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with a diagnosis of noncaridioembolic IS that developed within 7 days before the start of the protocol treatment
Patients with a responsible lesion identified by MRI
Patients with dyslipidemia (total chlolesterol > 6.0nmol/L) or under the treatment of dyslipidemia
Patients taking clopidogrel or aspirin as antiplatelet therapy when providing informed consent
Patients aged 40 to 85 years old when providing informed consent
Patients considered to be able to visit the study site
Patients who provided written informed consent
Key exclusion criteria
Patients with a history of acute myocardial infarction within six months
Patients with congestive heart failure or uncontrolled angina pectoris
Patients with a history of caridiovascular angioplasty within six months
Patients with severe liver or renal dysfunction
Patients with a malignant tumor requiring treatment
Patients with uncontrolled diabetes mellitus
Patients with secondary dyslipidemia (due to corticosteroid etc)
Patients with hemorrhagic diseases (eg. Hemophilia, hemorrhagic intestinal diseases, hemorrhage from gastrointesitinal tract and urinary tract, hemoptysis)
Patients with hypersensitivity to aspirin, clopidogrel or cilostazol
Patients scheduled to undergo any surgery during the study period
Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Aizawa |
Organization
Tokyo Medical University
Division name
Department of Neurology
Zip code
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan
TEL
+81-3-3342-6111
haizawa@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroo Terashi |
Organization
Tokyo Medical University
Division name
Department of Neurology
Zip code
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan
TEL
+81-3-3342-6111
Homepage URL
terashi@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Neurology, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京医科大学病院（東京都）Tokyo Medical University Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016172
