title: Efficacy and safety of combination antiplatelet therapies in patients with symptomatic intracranial atherosclerotic stenosis.
abstract: OBJECTIVE
  An optimal strategy for management of symptomatic intracranial atherosclerotic stenosis (ICAS) has not yet been established. We compared the efficacy of 2 combinations of antiplatelets, aspirin plus cilostazol (cilostazol group) verus aspirin plus clopidogrel (clopidogrel group), on the progression of ICAS, which is known to be associated with clinical stroke recurrence.
  
  
  METHODS
  In this investigator-initiated double-blind trial, 457 patients with acute symptomatic stenosis in the M1 segment of the middle cerebral artery or the basilar artery were randomly allocated into either a cilostazol group or a clopidogrel group. After 7 months of treatment, follow-up MR angiogram and MRI were performed. The primary end point was the progression of ICAS in comparison with stenosis on the baseline MR angiogram. Secondary end points included the occurrence of new ischemic lesions on MRI, composite of cardiovascular events, and major bleeding complications.
  
  
  RESULTS
  Cardiovascular events occurred in 15 of 232 patients (6.4%) in the cilostazol group and 10 of 225 (4.4%) in the clopidogrel group (P=0.312). Cilostazol did not reduce the progression of symptomatic ICAS (20 of 202) compared to clopidogrel (32 of 207) (odds ratio, 0.61; P=0.092), although favorable changes in serum lipoproteins were observed in the cilostazol group. There were no significant differences between the 2 groups with respect to new ischemic lesions (18.7% versus 12.0%; P=0.078) and major hemorrhagic complications (0.9% versus 2.6%; P=0.163).
  
  
  CONCLUSIONS
  This trial failed to show significant difference in preventing progression of ICAS and new ischemic lesions between the 2 combination antiplatelet therapies in the patients with symptomatic ICAS.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00130039.
authors.affiliation: Asan Medical Center, Department of Clinical Epidemiology and Biostatistics, University of Ulsan, Ulsan, Korea. sukwon@amc.seoul.kr
authors.forename: Sun U
authors.initials: SU
authors.lastname: Kwon
authors.forename: Keun-Sik
authors.initials: KS
authors.lastname: Hong
authors.forename: Dong-Wha
authors.initials: DW
authors.lastname: Kang
authors.forename: Jong-Moo
authors.initials: JM
authors.lastname: Park
authors.forename: Ju-Hun
authors.initials: JH
authors.lastname: Lee
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Cho
authors.forename: Kyung-Ho
authors.initials: KH
authors.lastname: Yu
authors.forename: Ja-Seong
authors.initials: JS
authors.lastname: Koo
authors.forename: K S Lawrence
authors.initials: KS
authors.lastname: Wong
authors.forename: Seung-Hoon
authors.initials: SH
authors.lastname: Lee
authors.forename: Kyung Bok
authors.initials: KB
authors.lastname: Lee
authors.forename: Dong-Eog
authors.initials: DE
authors.lastname: Kim
authors.forename: Sang-Wook
authors.initials: SW
authors.lastname: Jeong
authors.forename: Hee-Joon
authors.initials: HJ
authors.lastname: Bae
authors.forename: Byung-Chul
authors.initials: BC
authors.lastname: Lee
authors.forename: Moon-Ku
authors.initials: MK
authors.lastname: Han
authors.forename: Joung-Ho
authors.initials: JH
authors.lastname: Rha
authors.forename: Hahn Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Vincent C
authors.initials: VC
authors.lastname: Mok
authors.forename: Yong-Seok
authors.initials: YS
authors.lastname: Lee
authors.forename: Gyeong-Moon
authors.initials: GM
authors.lastname: Kim
authors.forename: Nijasri Charnnarong
authors.initials: NC
authors.lastname: Suwanwela
authors.forename: Sung-Cheol
authors.initials: SC
authors.lastname: Yun
authors.forename: Hyun-Wook
authors.initials: HW
authors.lastname: Nah
authors.forename: Jong S
authors.initials: JS
authors.lastname: Kim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000077407:Cilostazol; D000077144:Clopidogrel; D003251:Constriction, Pathologic / Q000188:drug therapy; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000188:drug therapy*; D007511:Ischemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077144:Clopidogrel; D000077407:Cilostazol; D013988:Ticlopidine