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Noncardioembolic Cerebral InfarctionPhase 4CSPS・comNCT01995370

Cilostazol Stroke Prevention Study for Antiplatelet Combination

A Phase 4 study testing aspirin, clopidogrel and cilostazol in people with Noncardioembolic Cerebral Infarction, run by Japan Cardiovascular Research Foundation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Noncardioembolic Cerebral Infarction
What is being tested?
aspirin, clopidogrel and cilostazol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,884 participants
Where
1 siteJapan
Study dates
13 Dec 2013to 7 Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment
  • Patients with a responsible lesion identified by MRI
  • Patients aged 20 to 85 years old when providing informed consent
  • Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent
  • Patients meeting at least one of the following criteria a-c:
  • at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)
Show all 18Show fewer
  • at least 50% stenosis of an extracranial artery (the common carotid artery，internal carotid artery，vertebral artery，brachiocephalic artery，or subclavian artery)
  • 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)
  • Patients considered to be able to visit the study site for ambulatory care throughout the observation period
  • Patients who provided written informed consent

Who cannot join

  • Patients with emboligenic heart disease
  • Patients taking any anticoagulant agents
  • Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker
  • Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period
  • Patients with a drug-eluting coronary stent implanted within one year
  • Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders
Show all 20Show fewer
  • Patients with a history of hypersensitivity to cilostazol
  • Patients with congestive heart failure or uncontrolled angina pectoris
  • Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)
  • Patients with severe liver or renal dysfunction
  • Women who are pregnant, breast-feeding, or of child-bearing potential
  • Patients with a malignant tumor requiring treatment
  • 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
  • Patients who are taking clopidogrel, and meet the following criterion:
  • ・History of hypersensitivity to clopidogrel
  • Patients who are participating in any other clinical studies
  • Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Japan Cardiovascular Research Foundation

    Osaka, 565-8565

Other trials in Japan

About this study

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

Being tested
aspirin, clopidogrel, cilostazol
Keywords
Noncardioembolic cerebral infarction, Dual antiplatelet therapy (DAPT), Cilostazol, Aspirin, Clopidogrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirinDrug

    Also called Bayaspirin

    Aspirin (81mg or 100mg) 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.

  • clopidogrelDrug

    Also called Plavix

    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.

  • cilostazolDrug

    Also called Pletaal OD Tablet

    Cilostazol (100mg twice daily) will be orally administered. 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.

Study groups in NCT01995370
Study groupRoleWhat they receive
Monotherapy groupActive comparatorAspirin (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.
Receives: Drug: aspirin; Drug: clopidogrel
DAPT groupExperimentalCilostazol (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.
Receives: Drug: aspirin; Drug: clopidogrel; Drug: cilostazol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours

    An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.

    Measured: every 6 months

Secondary outcomes (8)

  1. Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)]

    Measured: every 6 months

  2. SAH or ICH

    Measured: every 6 months

  3. IS or transient ischemic attack (TIA)

    Measured: every 6 months

  4. Death from any cause

    Measured: every 6 months

  5. Stroke (IS，ICH，SAH), myocardial infarction (MI), or vascular death

    Measured: every 6 months

  6. All vascular events: stroke, MI, and other vascular events

    Measured: every 6 months

  7. Adverse events and adverse drug reactions

    Measured: every 6 months

  8. Severe or life-threatening hemorrhage (GUSTO Criteria)

    Measured: every 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2013 (estimated)
  2. Study start13 Dec 2013
  3. Primary completion7 Dec 2018
  4. Study completion7 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,884 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01995370
Sponsor's protocol ID
021-TADD-1300-1
Other IDs
000012180
Acronym
CSPS・com
Status last verified
Mar 2019
First submitted
15 Nov 2013
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Koge J, Toyoda K, Koga M, Fukuda-Doi M, Uchiyama S, Kimura K, Hoshino H, Yamaguchi K, Okada Y, Sakai N, Miwa K, Minematsu K, Yamaguchi T; CSPS.com Trial Investigators. Effect of renal function on dual antiplatelet therapy using cilostazol for stroke prevention: a CSPS.com trial post hoc analysis. J Neurol Sci. 2025 Oct 15;477:123661. doi: 10.1016/j.jns.2025.123661. Epub 2025 Aug 18.

    PubMed 40845415

  • Toyoda K, Koga M, Tanaka K, Uchiyama S, Sunami H, Omae K, Kimura K, Hoshino H, Fukuda-Doi M, Miwa K, Koge J, Okada Y, Sakai N, Minematsu K, Yamaguchi T; CSPS.com Trial Investigators. Blood pressure during long-term cilostazol-based dual antiplatelet therapy after stroke: a post hoc analysis of the CSPS.com trial. Hypertens Res. 2024 Sep;47(9):2238-2249. doi: 10.1038/s41440-024-01742-3. Epub 2024 Jul 9.

    PubMed 38977876

  • Nishiyama Y, Kimura K, Otsuka T, Toyoda K, Uchiyama S, Hoshino H, Sakai N, Okada Y, Origasa H, Naritomi H, Houkin K, Yamaguchi K, Minematsu K, Matsumoto M, Tominaga T, Tomimoto H, Terayama Y, Yasuda S, Yamaguchi T; CSPS.com Trial Investigators. Dual Antiplatelet Therapy With Cilostazol for Secondary Prevention in Lacunar Stroke: Subanalysis of the CSPS.com Trial. Stroke. 2023 Mar;54(3):697-705. doi: 10.1161/STROKEAHA.122.039900. Epub 2023 Feb 3.

    PubMed 36734235

  • Uchiyama S, Toyoda K, Okamura S, Omae K, Hoshino H, Kimura K, Kitagawa K, Minematsu K, Yamaguchi T. Dual antiplatelet therapy with cilostazol in stroke patients with extracranial arterial stenosis or without arterial stenosis: A subgroup analysis of the CSPS.com trial. Int J Stroke. 2023 Apr;18(4):426-432. doi: 10.1177/17474930221112343. Epub 2022 Jul 21.

    PubMed 35762581

  • Toyoda K, Omae K, Hoshino H, Uchiyama S, Kimura K, Miwa K, Minematsu K, Yamaguchi K, Suda Y, Toru S, Kitagawa K, Ihara M, Koga M, Yamaguchi T; CSPS.com Trial Investigators. Association of Timing for Starting Dual Antiplatelet Treatment With Cilostazol and Recurrent Stroke: A CSPS.com Trial Post Hoc Analysis. Neurology. 2022 Mar 8;98(10):e983-e992. doi: 10.1212/WNL.0000000000200064. Epub 2022 Jan 24.

    PubMed 35074890

  • Uchiyama S, Toyoda K, Omae K, Saita R, Kimura K, Hoshino H, Sakai N, Okada Y, Tanaka K, Origasa H, Naritomi H, Houkin K, Yamaguchi K, Isobe M, Minematsu K, Matsumoto M, Tominaga T, Tomimoto H, Terayama Y, Yasuda S, Yamaguchi T. Dual Antiplatelet Therapy Using Cilostazol in Patients With Stroke and Intracranial Arterial Stenosis. J Am Heart Assoc. 2021 Oct 19;10(20):e022575. doi: 10.1161/JAHA.121.022575. Epub 2021 Oct 8.

    PubMed 34622679

  • Hoshino H, Toyoda K, Omae K, Ishida N, Uchiyama S, Kimura K, Sakai N, Okada Y, Tanaka K, Origasa H, Naritomi H, Houkin K, Yamaguchi K, Isobe M, Minematsu K, Matsumoto M, Tominaga T, Tomimoto H, Terayama Y, Yasuda S, Yamaguchi T; CSPS.com Trial Investigators. Dual Antiplatelet Therapy Using Cilostazol With Aspirin or Clopidogrel: Subanalysis of the CSPS.com Trial. Stroke. 2021 Nov;52(11):3430-3439. doi: 10.1161/STROKEAHA.121.034378. Epub 2021 Aug 18.

    PubMed 34404237

  • Toyoda K, Uchiyama S, Yamaguchi T, Easton JD, Kimura K, Hoshino H, Sakai N, Okada Y, Tanaka K, Origasa H, Naritomi H, Houkin K, Yamaguchi K, Isobe M, Minematsu K; CSPS.com Trial Investigators. Dual antiplatelet therapy using cilostazol for secondary prevention in patients with high-risk ischaemic stroke in Japan: a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2019 Jun;18(6):539-548. doi: 10.1016/S1474-4422(19)30148-6.

    PubMed 31122494

  • Toyoda K, Uchiyama S, Hoshino H, Kimura K, Origasa H, Naritomi H, Minematsu K, Yamaguchi T; CSPS.com Study Investigators. Protocol for Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com): a randomized, open-label, parallel-group trial. Int J Stroke. 2015 Feb;10(2):253-8. doi: 10.1111/ijs.12420. Epub 2014 Dec 8.

    PubMed 25487817

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing aspirin, clopidogrel and cilostazol in people with Noncardioembolic Cerebral Infarction, run by Japan Cardiovascular Research Foundation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours (time frame: every 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01995370, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.

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