The efficacy and safety of cilostazol in ischemic stroke patients with peripheral arterial disease (SPAD): Protocol of a randomized, double-blind, placebo-controlled multicenter trial

International Journal of Stroke

Volumn 10, Issue 1, 2015, Pages 123-127

  Jeng, Jiann Shing ^a   Sun, Yu ^b   Lee, Jiunn Tay ^c   Lin, Ruey Tay ^d   Chen, Chih Hung ^e   Po, Helen L ^f   Lin, Huey Juan ^g   Liu, Chung Hsiang ^h   Sun, Ming Hui ⁱ   Sun, Mu Chien ^j   Chern, Chang Ming ^k   Lien, Li Ming ^l   Chiu, Hou Chang ^l   Hu, Han Hwa ^k   Chiou, Hung Yi ^m   Chen, Sien Tsong ⁿ   Ma, Henry ^o,p   Hsu, Chung Y ^h,q  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b EN CHU KONG HOSPITAL   (Taiwan)

^c TRI SERVICE GENERAL HOSPITAL   (Taiwan)

^d KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^e NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^f MACKAY MEMORIAL HOSPITAL   (Taiwan)

^g CHI MEI MEDICAL CENTER   (Taiwan)

^h CHINA MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

ⁱ KUANG TIEN GENERAL HOSPITAL   (Taiwan)

^j CHANGHUA CHRISTIAN HOSPITAL   (Taiwan)

^k TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^l SHIN KONG WU HO SU MEMORIAL HOSPITAL   (Taiwan)

^m TAIPEI MEDICAL UNIVERSITY   (Taiwan)

ⁿ CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^o FLOREY INSTITUTE OF NEUROSCIENCE AND MENTAL HEALTH   (Australia)

^p MONASH UNIVERSITY   (Australia)

^q CHINA MEDICAL UNIVERSITY   (Taiwan)

more..

Author keywords

Ankle brachial index; Aspirin; Cilostazol; Intima media thickness; Ischemic stroke; Peripheral arterial disease

Indexed keywords

ACETYLSALICYLIC ACID; CILOSTAZOL; PLACEBO; FIBRINOLYTIC AGENT; TETRAZOLE DERIVATIVE;

ADULT; ANKLE BRACHIAL INDEX; ARTERIAL WALL THICKNESS; ARTICLE; ATHEROSCLEROSIS; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CONTROLLED STUDY; DEATH; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MIDDLE AGED; MONOTHERAPY; MORBIDITY; MULTICENTER STUDY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; TRANSIENT ISCHEMIC ATTACK; UNSTABLE ANGINA PECTORIS; CLINICAL TRIAL; COMPLICATION; DRUG COMBINATION; FEMALE; MALE; METHODOLOGY; STROKE;

ASPIRIN; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FIBRINOLYTIC AGENTS; HUMANS; MALE; MIDDLE AGED; PERIPHERAL ARTERIAL DISEASE; RESEARCH DESIGN; STROKE; TETRAZOLES;

EID: 84916238893     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1111/ijs.12384     Document Type: Article

References (40)

1. Banerjee A, Fowkes FG, Rothwell PM. Associations between peripheral artery disease and ischemic stroke: implications for primary and secondary prevention. Stroke 2010; 41:2102-2107.
2. Carolei A, Chamorro A, Laloux P etal. Identification and management of polyvascular disease in patients with noncardioembolic ischaemic stroke. Int J Stroke 2008; 3:237-248.
3. Röther J, Alberts MJ, Touzé E etal. Risk factor profile and management of cerebrovascular patients in the REACH Registry. Cerebrovasc Dis 2008; 25:366-374.
4. Ovbiagele B. Association of ankle-brachial index level with stroke. J Neurol Sci 2009; 276:14-17.
5. Bhatt DL, Steg PG, Ohman EM etal. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA 2006; 295:180-189.
6. Leys D, Woimant F, Ferrières J etal. Detection and management of associated atherothrombotic locations in patients with a recent atherothrombotic ischemic stroke: results of the DETECT survey. Cerebrovasc Dis 2006; 21:60-66.
7. Weimar C, Goertler M, Röther J etal. Systemic Risk Score Evaluation in Ischemic Stroke Patients (SCALA): a prospective cross sectional study in 85 German stroke units. J Neurol 2007; 254:1562-1568.
8. Roquer J, Ois A, Rodríguez-Campello A etal. Atherosclerotic burden and early mortality in acute ischemic stroke. Arch Neurol 2007; 64:699-704.
9. Agnelli G, Cimminiello C, Meneghetti G, Urbinati S. Low ankle-brachial index predicts an adverse 1-year outcome after acute coronary and cerebrovascular events. J Thromb Haemost 2006; 4:2599-2606.
10. Topakian R, Nanz S, Rohrbacher B, Koppensteiner R, Aichner FT, OECROSS Study Group. High prevalence of peripheral arterial disease in patients with acute ischaemic stroke. Cerebrovasc Dis 2010; 29:248-254.
11. Berger JS, Krantz MJ, Kittelson JM, Hiatt WR. Aspirin for the prevention of cardiovascular events in patients with peripheral artery disease: a meta-analysis of randomized trials. JAMA 2009; 301:1909-1919.
12. Go AS, Mozaffarian D, Roger VL etal. Heart disease and stroke statistics-2013 update: a report from the American Heart Association. Circulation 2013; 127:e6-245.
13. Mohan KM, Wolfe CD, Rudd AG, Heuschmann PU, Kolominsky-Rabas PL, Grieve AP. Risk and cumulative risk of stroke recurrence: a systematic review and meta-analysis. Stroke 2011; 42:1489-1494.
14. Busch MA, Lutz K, Rohl JE, Neuner B, Masuhr F. Low ankle-brachial index predicts cardiovascular risk after acute ischemic stroke or transient ischemic attack. Stroke 2009; 40:3700-3705.
15. Tsivgoulis G, Bogiatzi C, Heliopoulos I etal. Low ankle-brachial index predicts early risk of recurrent stroke in patients with acute cerebral ischemia. Atherosclerosis 2012; 220:407-412.
16. Manzano JJ, De Silva DA, Pascual JL, Chang HM, Wong MC, Chen CP. Associations of ankle-brachial index (ABI) with cerebral arterial disease and vascular events following ischemic stroke. Atherosclerosis 2012; 223:219-222.
17. Lackland DT, Elkind MS, D'Agostino R Sr etal. Inclusion of stroke in cardiovascular risk prediction instruments: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2012; 43:1998-2027.
18. Antithormbotic 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.
19. Antithrombotic Trialists' (ATT) Collaboration, Baigent C, Blackwell L etal. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373:1849-1860.
20. Basili S, Raparelli V, Vestri A, Di Tanna GL, Violi F. Comparison of efficacy of antiplatelet treatments for patients with claudication. A meta-analysis. Thromb Haemost 2010; 103:766-773.
21. Goto S. Cilostazol: potential mechanism of action for antithrombotic effects accompanied by a low rate of bleeding. Atheroscler Suppl 2005; 6:3-11.
22. Ikeda Y, Sudo T, Kimura Y. Cilostazol; in Michelson AD (ed.): Platelets, 2nd edn. Amsterdam, Elsevier, 2006:1181-1191.
23. Pearce L, Ghosh J, Counsell A, Serracino-Inglott F. Cilostazol and peripheral arterial disease. Expert Opin Pharmacother 2008; 9:2683-2690.
24. Anderson JL, Halperin JL, Albert NM etal. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2013; 127:1425-1443.
25. 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.
26. Fowkes FG, Rudan D, Rudan I etal. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 2013; 382:1329-1340.
27. Shirai K, Utino J, Otsuka K, Takata M. A novel blood pressure-independent arterial wall stiffness parameter; cardio-ankle vascular index (CAVI). J Atheroscler Thromb 2006; 13:101-107.
28. Espinola-Klein C, Rupprecht HJ, Bickel C etal. Different calculations of ankle-brachial index and their impact on cardiovascular risk prediction. Circulation 2008; 118:961-967.
29. Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation 2010; 121:2584-2591.
30. Money SR, Herd JA, Isaacsohn JL etal. Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease. J Vasc Surg 1998; 27:267-275.
31. Alberts MJ, Bhatt DL, Mas JL etal. Three-year follow-up and event rates in the international REduction of Atherothrombosis for Continued Health Registry. Eur Heart J 2009; 30:2318-2326.
32. Steg PG, Bhatt DL, Wilson PW etal. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA 2007; 297:1197-1206.
33. Palacio S, Hart RG, Pearce LA etal. Effect of addition of clopidogrel to aspirin on stroke incidence: meta-analysis of randomized trials. Int J Stroke 2013. doi: 10.1111/ijs.12050.
34. 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.
35. 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.
36. Poredo P, Jezovnik ML. Is aspirin still the drug of choice for management of patients with peripheral arterial disease? Vasa 2013; 42:88-95.
37. Uchiyama S, Demaerschalk BM, Goto S etal. Stroke prevention by cilostazol in patients with atherothrombosis: meta-analysis of placebo-controlled randomized trials. J Stroke Cerebrovasc Dis 2009; 18:482-490.
38. Kwon SU, Cho YJ, Koo JS etal. Cilostazol prevents the progression of the symptomatic intracranial arterial symptomatic intracranial arterial stenosis: the Multicenter Double-Blind Placebo-Controlled Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis. Stroke 2005; 36:782-786.
39. Olin JW, Allie DE, Belkin M etal. 2010 performance measures for adults with peripheral artery disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures, the American College of Radiology, the Society for Cardiac Angiography and Interventions, the Society for Interventional Radiology, the Society for Vascular Medicine, the Society for Vascular Nursing, and the Society for Vascular Surgery. Circulation 2010; 122:2583-2618.
40. Lorenz MW, Markus HS, Bots ML, Rosvall M, Sitzer M. Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation 2007; 115:459-467.