[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).

Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.

Modified Rankin Score:

0 - No symptoms.

• - No significant disability. Able to carry out all usual activities, despite some symptoms.
• - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
• - Moderate disability. Requires some help, but able to walk unassisted.
• - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
• - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
• - Dead.

Disability defined as mRS > 1.

Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables.

Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):

0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke.

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

EQ-5D index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

EQ-5D index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

PLATO Major bleeding is defined as a bleed that is any one of:

• Fatal
• Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)
• Intrapericardial bleed with cardiac tamponade
• Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery
• Significantly disabling (eg. intraocular with permanent vision loss)
• Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)
• Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.

Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).