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. 2009 Oct 7;2009(4):CD001246. doi: 10.1002/14651858.CD001246.pub2

AAASPS.

Methods R = randomisation sequence in blocks varying randomly in size from 2 to 8 
 Ratio of those receiving ticlopidine to aspirin was 1:1 
 Study participants registered by local study site personnel via a dedicated automated telephone registration system 
 C = access to code restricted to chief study statistician 
 Blinding: patients and all study personnel with exception of study statistician 
 Ticlopidine and aspirin tablets dispensed with physically identical placebo from plastic bottles
Participants 62 centres in the USA 
 1809 patients randomised, 1995 to 2001 
 Black (African‐American race, 29 to 85 years of age, noncardioembolic ischaemia stroke onset 7 to 90 days before randomisation 
 CT or MRI image consistent with cerebral infarct and measurable neurological deficit correlating with infarct 
 Mean age: 61 years 
 Gender: 47% male 
 Race: 100% Black 
 Comparability of groups: age, gender and vascular risk factors 
 Ex crit: TIA, SAH, cardiac source embolism, iatrogenic stroke, non‐atherosclerotic stroke, post‐operative stroke, carotid endarterectomy as primary treatment measure, mean arterial blood pressure > 130 mmHg on 3 consecutive days, modified Barthel index < 10, dementia or neurodegenerative disease, severe co‐morbid condition such as cancer, allergy or insensitivity to study drugs, woman of childbearing potential, GI tract bleeding, bleeding diathesis, platelet or other haematological abnormality, haematuria, positive faecal occult blood test, prolonged prothrombin time or partial thromboplastin time, blood urea > 40mg/dL, serum creatinine > 2mg/dL, thrombocytopenia, neutropenia, liver function tests > 2 times upper limit of normal
Interventions Ticlopidine 250 mg twice daily versus aspirin 325 mg twice daily
Outcomes Primary: composite of recurrent stroke, MI or vascular death 
 Secondary: stroke, MI, vascular death, any death
Notes Co: median compliance was 90% for ticlopidine and 92% for aspirin 
 Duration of follow up: mean follow up was 1.54 years 
 Lost to follow up: 137 patients (15.2%) in the ticlopidine group and 121 (13.3%) in aspirin group were either lost to follow‐up or voluntarily withdrew 
 Most of these were due to voluntary withdrawals but it is uncertain whether follow‐up data was available for these patients