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

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 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


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

Value
https://center6.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