Protocol for Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com): A randomized, open-label, parallel-group trial

International Journal of Stroke

Volumn 10, Issue 2, 2015, Pages 253-258

  Toyoda, Kazunori ^a   Uchiyama, Shinichiro ^b   Hoshino, Haruhiko ^c   Kimura, Kazumi ^d   Origasa, Hideki ^e   Naritomi, Hiroaki ^f   Minematsu, Kazuo ^a   Yamaguchi, Takenori ^a  

^a NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^b INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE   (Japan)

^c SAISEIKAI CENTRAL HOSPITAL   (Japan)

^d NIPPON MEDICAL SCHOOL GRADUATE SCHOOL OF MEDICINE   (Japan)

^e UNIVERSITY OF TOYAMA   (Japan)

^f Senri Chuo Hospital   (Japan)

Author keywords

Aspirin; Cerebral infarction; Cilostazol; Clinical trial; Clopidogrel; Dual antiplatelet therapy; Ischemic stroke; Stroke prevention

Indexed keywords

ACETYLSALICYLIC ACID; CILOSTAZOL; CLOPIDOGREL; ANTITHROMBOCYTIC AGENT; PHOSPHODIESTERASE III INHIBITOR; TETRAZOLE DERIVATIVE; TICLOPIDINE;

ARTICLE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; OPEN STUDY; PARALLEL DESIGN; PREVENTION STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; SECONDARY PREVENTION; TREATMENT OUTCOME; AGED; ANALOGS AND DERIVATIVES; BRAIN ISCHEMIA; COMBINATION DRUG THERAPY; METHODOLOGY; STROKE;

AGED; ASPIRIN; BRAIN ISCHEMIA; DRUG THERAPY, COMBINATION; HUMANS; PHOSPHODIESTERASE 3 INHIBITORS; PLATELET AGGREGATION INHIBITORS; RECURRENCE; RESEARCH DESIGN; STROKE; TETRAZOLES; TICLOPIDINE;

EID: 84921601779     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1111/ijs.12420     Document Type: Article

References (35)

1. Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324:71-86.
2. Chimowitz MI, Lynn MJ, Howlett-Smith H etal. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med 2005; 352:1305-1316.
3. Kasner SE, Chimowitz MI, Lynn MJ etal. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation 2006; 113:555-563.
4. Nicolaides AN, Kakkos SK, Kyriacou E etal. Asymptomatic internal carotid artery stenosis and cerebrovascular risk stratification. J Vasc Surg 2010; 52:1486-1496.
5. Kamouchi M, Kumagai N, Okada Y, Origasa H, Yamaguchi T, Kitazono T. Risk score for predicting recurrence in patients with ischemic stroke: the Fukuoka stroke risk score for Japanese. Cerebrovasc Dis 2012; 34:351-357.
6. Diener HC, Ringleb PA, Savi P. Clopidogrel for the secondary prevention of stroke. Expert Opin Pharmacother 2005; 6:755-764.
7. Diener HC, Cunha L, Forbes C, Sivenius J, Smets P, Lowenthal A. European Stroke Prevention Study. 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci 1996; 143:1-13.
8. The ESPRIT Study Group. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Lancet 2006; 367:1665-1673.
9. Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis 2011; 31:601-613.
10. Markus HS, Droste DW, Kaps M etal. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation 2005; 111:2233-2240.
11. Kennedy J1, Hill MD, Ryckborst KJ etal. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol 2007; 6:961-969.
12. Wong KS, Chen C, Fu J etal. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol 2010; 9:489-497.
13. Wang Y, Wang Y, Zhao X etal. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med 2013; 369:11-19.
14. Diener HC, Bogousslavsky J, Brass LM etal. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet 2004; 364:331-337.
15. Bhatt DL, Fox KA, Hacke W etal. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med 2006; 354:1706-1717.
16. The SPS 3 Investigators. Effects of clopidogrel added to aspirin in patients with recent lacunar stroke. N Engl J Med 2012; 367:817-825.
17. Gotoh F, Tohgi H, Hirai S etal. Cilostazol stroke prevention study: a placebo-controlled double-blind trial for secondary prevention of cerebral infarction. J Stroke Cerebrovasc Dis 2000; 9:147-157.
18. Shinohara Y, Katayama Y, Uchiyama S etal. Cilostazol for prevention of secondary stroke (CSPS 2): an aspirin-controlled, double-blind, randomised non-inferiority trial. Lancet Neurol 2010; 9:959-968.
19. Kwon SU, Cho YJ, Koo JS etal. Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis: the multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis. Stroke 2005; 36:782-786.
20. Kwon SU, Hong KS, Kang DW etal. Efficacy and safety of combination antiplatelet therapies in patients with symptomatic intracranial atherosclerotic stenosis. Stroke 2011; 42:2883-2890.
21. The CATHARSIS Study Group. Final Results of Cilostazol-Aspirin Therapy Against Recurrent Stroke with Intracranial artery Stenosis (CATHARSIS). Stroke 2013; 44:AWP423.
22. Wilhite DB, Comerota AJ, Schmieder FA, Throm RC, Gaughan JP, Rao AK. Managing PAD with multiple platelet inhibitors: the effect of combination therapy on bleeding time. J Vasc Surg 2003; 38:710-713.
23. Hiatt WR, Money SR, Brass EP. Long-term safety of cilostazol in patients with peripheral artery disease: the CASTLE study (Cilostazol: a study in long-term effects). J Vasc Surg 2008; 47:330-336.
24. Sakurai R, Koo BK, Kaneda H, Bonneau HN, Nagai R. Cilostazol added to aspirin and clopidogrel reduces revascularization without increases in major adverse events in patients with drug-eluting stents: a meta-analysis of randomized controlled trials. Int J Cardiol 2013; 167:2250-2258.
25. Ishiguro M, Mishiro K, Fujiwara Y etal. Phosphodiesterase-III inhibitor prevents hemorrhagic transformation induced by focal cerebral ischemia in mice treated with tPA. PLoS ONE 2010; 5:e15178.
26. Hase Y, Okamoto Y, Fujita Y etal. Cilostazol, a phosphodiesterase inhibitor, prevents no-reflow and hemorrhage in mice with focal cerebral ischemia. Exp Neurol 2012; 233:523-533.
27. Kasahara Y, Nakagomi T, Matsuyama T, Stern D, Taguchi A. Cilostazol reduces the risk of hemorrhagic infarction after administration of tissue-type plasminogen activator in a murine stroke model. Stroke 2012; 43:499-506.
28. The GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993; 329:673-682.
29. Suzuki N, Sato M, Houkin K etal. One-year atherothrombotic vascular events rates in outpatients with recent non-cardioembolic ischemic stroke: the EVEREST (Effective Vascular Event REduction after STroke) registry. J Stroke Cerebrovasc Dis 2012; 21:245-253.
30. Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med 1992; 11:179-191.
31. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 1971; 44:793-797.
32. Peto R, Pike MC, Armitage P etal. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976; 34:585-612.
33. Gorelick PB, Wong KS, Bae HJ, Pandey DK. Large artery intracranial occlusive disease: a large worldwide burden but a relatively neglected frontier. Stroke 2008; 39:2396-2399.
34. Shen AY, Yao JF, Brar SS, Jorgensen MB, Chen W. Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol 2007; 50:309-315.
35. van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol 2010; 9:167-176.