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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012180
Receipt No. R000014239
Scientific Title Cilostazol Stroke Prevention Study for Antiplatelet Combination
Date of disclosure of the study information 2013/10/31
Last modified on 2019/03/25

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Basic information
Public title Cilostazol Stroke Prevention Study for Antiplatelet Combination
Acronym CSPS.com (Cilostazol Stroke Prevention Study. Combination)
Scientific Title Cilostazol Stroke Prevention Study for Antiplatelet Combination
Scientific Title:Acronym CSPS.com (Cilostazol Stroke Prevention Study. Combination)
Region
Japan

Condition
Condition Noncardioembolic cerebral infarction
Classification by specialty
Medicine in general Cardiology Neurology
Geriatrics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Recurrence of symptomatic ischemic stroke,with the symptoms lasting for at least 24 hours
(An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.)
Key secondary outcomes Efficacy
- Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)]
- SAH or ICH
- IS or transient ischemic attack (TIA)
- Death from any cause
- Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death
- All vascular events: stroke, MI, and other vascular events (e.g. aortic dissection or rupture; pulmonary embolism; heart failure, angina pectoris, or occlusive arteriosclerosis requiring hospitalization; revascularization of coronary artery, aorta, peripheral artery, etc.)

Safety
- Adverse events and adverse drug reactions
- Severe or life-threatening hemorrhage (GUSTO Criteria)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Monotherapy group:
Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily.
The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Interventions/Control_2 DAPT group:
Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily).
The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment
2) Patients with a responsible lesion identified by MRI
3) Patients aged 20 to 85 years old when providing informed consent
4) Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent
5) Patients meeting at least one of the following criteria a-c:
a. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)
b. at least 50% stenosis of an extracranial artery (the common carotid artery, internal carotid artery, vertebral artery, brachiocephalic artery, or subclavian artery)
c. Two or more of the following risk factors
- Aged 65 years or more
- Diabetes mellitus
- Hypertension
- Peripheral arterial disease
- Chronic kidney disease
- History of IS (excluding the index IS for this study)
- History of ischemic heart disease
- Smoking (only current smokers)
6) Patients considered to be able to visit the study site for ambulatory care throughout the observation period
7) Patients who provided written informed consent
Key exclusion criteria 1) Patients with emboligenic heart disease
2) Patients taking any anticoagulant agents
3) Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker
4) Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period
5) Patients with a drug-eluting coronary stent implanted within one year
6) Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders
7) Patients with a history of hypersensitivity to cilostazol
8) Patients with congestive heart failure or uncontrolled angina pectoris
9) Patients with thrombocytopenia (platelet count <= 100,000/mm3)
10) Patients with severe liver or renal dysfunction
11) Women who are pregnant, breast-feeding, or of child-bearing potential
12) Patients with a malignant tumor requiring treatment
13) Patients who are taking aspirin, and meet any of the following criteria:
- History of hypersensitivity to aspirin or salicylic acid analogues
- Current peptic ulcer
- Aspirin-induced asthma or its history
14) Patients who are taking clopidogrel, and meet the following criterion:
- History of hypersensitivity to clopidogrel
15) Patients who are participating in any other clinical studies
16) Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takenori Yamaguchi
Organization National Cerebral and Cardiovascular Center
Division name President emeritus
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email tyamaguc@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Ido
Organization Japan Cardiovascular Research Foundation
Division name Cilostazol Stroke Prevention Study. Combination secretariat
Zip code
Address Osaka Kogin Bldg.,4-1-1 Koraibashi,Chuo-ku,Osaka,541-0043,Japan
TEL 0120-05-3125
Homepage URL http://www.jcvrf.jp/research/shitei_kenkyu.html
Email prj-csps.cont.com@eps.co.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01995370
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 一宮西病院（愛知県）／Ichinomiyanishi Hospital(Aichi)、釧路労災病院（北海道）／Kushiro Rosai Hospital(Hokkaido)、由利組合総合病院（秋田県）／Yuri Kumiai General Hospital(Akita)／東京女子医科大学病院（東京都）／Tokyo Women's Medical University Hospital(Tokyo)、新渡戸記念中野総合病院（東京都）／Nitobe Memorial Nakano General Hospital(Tokyo)、道東脳神経外科病院（北海道）／Doutou neurosurgery(Hokkaido)、神戸市立医療センター中央市民病院（兵庫県）／Kobe City Medical Center General Hospital(Hyogo)、城山病院（大阪府）／Shiroyama Hospital(Osaka)、宇部興産株式会社中央病院（山口県）／Ube Kohsan Central Hospital(Yamaguchi)、神戸掖済会病院（兵庫県）／Kobe Ekisaikai Hospital(Hyogo)、聖麗メモリアル病院（茨城県）／Seirei Memorial Hospital(Ibaragi)、黒部市民病院（富山県）／Kurobe City Hospital(Toyama)、さくら会病院（大阪府）／Sakurakai Hospital(Osaka)、鹿児島医療センター（鹿児島県）／Kagoshima Medical Center(Kagoshima)、小樽市立病院（北海道）／Otaru General Hospital(Hokkaido)、国立循環器病研究センター（大阪府）／National Cerebral and Cardiovascular Center(Osaka)、佐賀大学医学部付属病院（佐賀県）／Saga University Hospital(Saga)、北里大学メディカルセンター（埼玉県）／Kitasato University Medical Center(Saitama)、柏葉脳神経外科病院（北海道）／Kashiwaba Neurosurgical Hospital(Hokkaido)、伊達赤十字病院（北海道）／Date Red Cross Hospital(Hokkaido)、大同病院（愛知県）／Daido Hospital(Aichi)、市立敦賀病院（福井県）／Municipal Tsuruga Hospital(Fukui)、東邦大学医療センター大森病院（東京都）／Toho University Omori Medical Center(Tokyo)、東京山手メディカルセンター（東京都）／Tokyo Yamate Medical Center(Tokyo)、姫路赤十字病院（兵庫県）／Japanese Red Cross Society Himeji Hospital(Hyogo)、洲本伊月病院（兵庫県）／Sumoto Itsuki Hospital(Hyogo)、聖マリア病院（福岡県）／St.Mary's Hospital(Fukuoka)、仙台医療センター（宮城県）／Sendai Medical Center(Miyagi)、島根大学医学部附属病院（島根県）／Shimane University Hospital(Shimane)、高木病院（福岡県）／Takagi Hospital(Fukuoka)、中村記念病院（北海道）／Nakamura　Memorial Hospital(Hokkaido)、旭川医療センター（北海道）／Asahikawa Meidical Center(Hokkaido)、富山大学附属病院（富山県）／Toyama University Hospital(Toyama)、九州医療センター（福岡県）／Kyushu Medical Center(Fukuoka)、岡山赤十字病院（岡山県）／Japan Red Cross Okayama Hospital(Okayama)、札幌白石記念病院（北海道）／Sapporo Shiroishi Memorial Hospital(Hokkaido)、旭川リハビリテーション病院（北海道）／Asahikawa Rehabilitation Hospital(Hokkaido)、総合南東北病院（福島県）／Southern TOHOKU General Hospital(Fukushima)、東京慈恵会医科大学附属病院（東京都）／Jikei University(Tokyo)、済生会横浜市東部病院（神奈川県）／Saiseikai Yokohamashi Tobu Hospital(Kanagawa)、横浜新都市脳神経外科病院（神奈川県）／Yokohamashintoshi Neurosurgical Hospital(Kanagawa)、兵庫医科大学病院（兵庫県）／Hyogo College of Medicine Hospital(Hyogo)、藤枝平成記念病院（静岡県）／Fujieda Heisei Memorial Hospital(Shizuoka)、旭川赤十字病院（北海道）／Japanese Red Cross Asahikawa Hospital(Hokkaido)、製鉄記念八幡病院（福岡県）／Steel Memorial Yawata Hospital(Fukuoka)、川崎医科大学総合医療センター（岡山県）／Kawasaki Medical School General Medical Center(Okayama)、大川原脳神経外科病院（北海道）／Ohkawara Neurosurgical Hospital(Hokkaido)、留萌セントラルクリニック（北海道）／Rumoecentoral clinic(Hokkaido)、岩手医科大学付属病院（岩手県）／Iwate Medical University (Iwate)、福島赤十字病院（福島県）／Japanese Red Cross　Fukushima Hospital(Fukushima)、東京医療センター（東京都）／Tokyo Medical Center(Tokyo)、順天堂大学医学部附属順天堂医院（東京都）／Juntendo University Hospital(Tokyo)、順天堂大学医学部附属静岡病院（静岡県）／Juntendo University Shizuoka Hospital(Shizuoka）、安城更生病院（愛知県）／Anjo Kosei Hospital(Aichi)、トヨタ記念病院（愛知県）／TOYOTA Memorial Hospital(Aichi)、豊田厚生病院（愛知県）／Toyota Kosei Hospital(Aichi)、市立四日市病院（三重県）／Yokkaichi Municipal Hospital(Mie)、美原記念病院（群馬県）／Mihara Memorial Hospital(Gunma)、他231施設

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.webmd.com/stroke/news/20190207/drug-may-be-safer-option-against-repeat-stroke#1
Number of participants that the trial has enrolled
Results 
The study found the risk of another ischemic stroke was halved for patients who took Pletal plus aspirin or clopidogrel, versus those who took aspirin or clopidogrel alone.
Specially, 29 of 913 patients (3.2 percent) who took Pletal plus another blood thinner went on to have another stroke, compared to 64 of 926 patients (6.9 percent) who took aspirin or clopidogrel alone, the investigators found.
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 Main results already published
Date of protocol fixation
2013 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 10 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 07 Day
Date trial data considered complete
2018 Year 12 Month 07 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 31 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014239

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