drugset / Trial / NCT01995370
Cilostazol Stroke Prevention Study for Antiplatelet Combination
Phase 4
Completed
1884 enrolled
Japan Cardiovascular Research Foundation
Otsuka Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelPrevention
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
Timeline
- Start
- 2013-12-13
- Primary completion
- 2018-12-07
- Completion
- 2018-12-07
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 81 mg | Oral |
| Subject | Aspirin | Small molecule | 100 mg | Oral |
| Subject | Cilostazol | Small molecule | 100 mg | Oral |
| Subject | Clopidogrel | Small molecule | 50 mg | Oral |
| Subject | Clopidogrel | Small molecule | 75 mg | Oral |