CASISP 2008

Methods	R: computer‐based stratified block randomisation on basis of pre‐established scheme, stratified according to each site, aspirin‐controlled trial C: double dummy: aspirin and cilostazol pills made to look the same B: double‐blind: patients and clinicians, radiologists blinded to clinical data
Participants	Multicentre, China 720 patients randomised (2004 to 2005) Mean age: 60.2 years (18 to 75 years) Sex: 495 male, 225 female Inclusion criteria: cerebral infarction 1 to 6 months before entry, confirmed with neuroimaging, modified Rankin scale score of less than 4 at enrolment Exclusion criteria: history of intracranial haemorrhage, stroke secondary to cardiogenic embolism, serious damage of motorial function, dementia, serious complications or comorbidity (uncontrolled accelerated type of hypertension, BP > 180/120 mmHg, diabetic acidosis, heart failure, renal failure, hepatocirrhosis, malignant tumour), contraindication of cilostazol and aspirin, need for co‐medication of other antiplatelet agents, anticoagulants or fibrinolytic drugs, active peptic ulcer, pregnancy or breast feeding Patients with hypertension or high lipid concentrations were given antihypertensive drugs or statins, respectively, and were seen by doctors every month during the follow‐up period. Liver and kidney function, electrocardiogram, and lipid profiles were monitored in all patients every 3 months
Interventions	Rx: cilostazol 100 mg twice daily oral versus aspirin 100 mg once daily oral Duration of treatment: 12 months
Outcomes	Primary outcomes: stroke recurrence (ischaemic, intracerebral haemorrhage, subarachnoid haemorrhage) Secondary outcomes: > 1 stroke, new myocardial infarction, transient ischaemic attack, vascular event (pulmonary embolism, deep vein thrombosis, peripheral arterial occlusive disease), death from vascular causes, death from all causes
Notes	360 participants in aspirin arm intention‐to‐treat analysis and 359 participants in cilostazol arm Compliance on aspirin: 47 discontinued, 3 died; reasons for withdrawal: 25 with adverse effects, 8 did not follow protocol, 6 lost to follow up, 8 withdrew due to other reasons, 3 died (1 myocardial infarction, 1 unknown, 1 drowned). Cilostazol: 35 discontinued, 5 died; reasons for withdrawal: 15 with adverse effects, 3 lack of effect, 7 did not follow protocol, 3 lost to follow up, 7 due to other causes, 5 died (2 myocardial infarction, 1 liver cancer, 1 pancreatitis, 1 suicide)
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	Double‐dummy, all pills made to look the same
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind (patients, clinicians) and radiologists reviewing reports
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients lost to follow up accounted for
Selective reporting (reporting bias)	Low risk	All selected patients accounted for
Other bias	Low risk	Free of detection bias, appropriate analysis