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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013864
Receipt No. 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

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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
Email 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
Email terashi@tokyo-med.ac.jp

Sponsor
Institute Department of Neurology, Tokyo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016172

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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