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| ID | Type | Description | Link |
|---|---|---|---|
| 000012180 | Other Identifier | UMIN |
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy group | Active Comparator | 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. |
|
| DAPT group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours | An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke. | every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] | every 6 months | |
| SAH or ICH | every 6 months | |
| IS or transient ischemic attack (TIA) |
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Inclusion Criteria:
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)
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
Patients considered to be able to visit the study site for ambulatory care throughout the observation period
Patients who provided written informed consent
Exclusion Criteria:
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
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Takenori Yamaguchi, President emeritus | National Cerebral and Cardiovascular Center, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan Cardiovascular Research Foundation | Osaka | 565-8565 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40845415 | Derived | 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. | |
| 38977876 |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| clopidogrel | Drug | 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. |
|
|
| cilostazol | Drug | 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. |
|
|
| every 6 months |
| Death from any cause | every 6 months |
| Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death | every 6 months |
| All vascular events: stroke, MI, and other vascular events | every 6 months |
| Adverse events and adverse drug reactions | every 6 months |
| Severe or life-threatening hemorrhage (GUSTO Criteria) | every 6 months |
| Derived |
| 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. |
| 36734235 | Derived | 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. |
| 35762581 | Derived | 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. |
| 35074890 | Derived | 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. |
| 34622679 | Derived | 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. |
| 34404237 | Derived | 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. |
| 31122494 | Derived | 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. |
| 25487817 | Derived | 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. |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011804 | Quinolines |