The combined primary endpoint was a composite of total mortality plus the total number of cardiovascular and cerebrovascular events, including all recurrent events.
Cerebral complications were defined as intracerebral haemorrhage, recurrence of stroke, TIAs or PRIND. Cardiovascular complications were defined as any cardiovascular event, including MI and new heart failure.
Pre-defined secondary endpoints were the single components of the combined primary endpoint, as well as an assessment of functional status and cognitive function assessed by the mini mental state examination (MMSE), Barthel Index,
and Rankin Scale.
Mean follow-up of patients in the study was 2.5 years.