| Outcome Measures: |
Primary: Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage), Acute MI defined according to the Third Universal Definition of myocardial infarction (MI). Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke (fatal and non-fatal) including intracerebral haemorrhage and SAH which has been confirmed on appropriate imaging is excluded from the primary composite endpoint and included within the secondary endpoints., Over average 4 years follow-up | Secondary: Number of participants dying from any cause, Death from any cause, Average 4 years follow-up|Number of participants with major vascular events plus revascularisation, Primary outcome plus coronary and non coronary arterial revascularisation. It will include open and percutaneous coronary and non-coronary (including carotid, aortic and limb) procedures (as defined in Office of Population Censuses and Surveys OPCS-4 procedure codes) and will be ascertained from Hospital Episode Statistics (HES) data., Average 4 years follow-up|Number of participants with Non-fatal myocardial infarction, Non-fatal myocardial infarction. Acute MI defined according to the Third Universal Definition of myocardial infarction (MI)., Average 4 years follow-up|Health-related quality of life, mean utility score, Euroqol EQ-5D utility score derived from 5 states (scoring 1-5) converted to utility values using UK general population set, Average 4 years follow-up|Number of participants with intra-cranial haemorrhage, fatal and non fatal major extra cranial haemorrhage, Intra-cranial haemorrhage includes intracerebral haemorrhage, subarachnoid haemorrhage, subdural haemorrhage, and extradural haemorrhage. Extra-cranial haemorrhage is: * Fatal bleeding, or * Symptomatic bleeding in a critical area or organ, such as intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, or * Bleeding that leads to the transfusion of two or more units of whole blood or red cells In particular, to be classified as major, bleeds in a critical area or organ should: * Be associated with a symptomatic clinical presentation (not following an incidental finding) * Be the cause of the symptoms, Average 4 years follow-up|Number of participants with Fatal and non-fatal intra-cranial haemorrhage, Fatal and non-fatal intra-cranial haemorrhage as above It comprises primary haemorrhagic stroke(to distinguish from haemorrhagic transformation of ischaemic stroke) ii)other intra-cranial haemorrhage (adjudicated). Intra-cranial haemorrhage will be sub categorised as traumatic and non-traumatic., Average 4 years follow-up|Number of participants with Fatal and non-fatal major extra-cranial haemorrhage, Fatal and non-fatal major extra-cranial haemorrhage as above. Categorised as i) upper-gastro-intestinal ii) lower gastro-intestinal iii) sight threatening ocular iv)multiple trauma v) other, Average 4 years follow-up|Number of participants with Clinically relevant non major bleeding (hospitalised), Defined in accordance with the International Society on Thrombosis and Haemostasis (ISTH) as any sign or symptom of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: • Leading to hospitalisation This definition excludes all minor bleeding episodes that lead to medical evaluation involving direct patient contact., Average 4 years follow-up|Number of participants with Non-fatal stroke, Non-fatal stroke excluding confirmed intracranial haemorrhage. Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke ( including intracerebral haemorrhage and sub-arachnoid haemorrhage) which has been confirmed on appropriate imaging is excluded., Average 4 years follow-up|Number of participants with Cardiovascular death, Cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage)., Average 4 years follow-up|Number of participants with fatal and non fatal major extra-cranial haemorrhage and clinically relevant non major bleed (if hospitalised), Definitions above, Average 4 years follow-up | Other: Number of participants with transient ischaemic attack, A transient episode of neurological dysfunction caused by focal brain spinal cord or retinal ischemia without acute infarction, Average 4 years follow-up|Number of Unplanned hospitalisations per participant, Defined as an official admission that is for a duration greater than 24 hours or a minimum of 2 calendar days where exact time of stay is unavailable., Average 4 years follow-up|Number of participants with new diagnosis of cancer, Any new cancer diagnosis excluding non melanotic skin cancer, Average 4 years follow-up|Number of participants with CKD progression, Defined as at least one of: * \>30% fall in eGFR over two years, or * need for renal replacement therapy or 50% decline in eGFR, or * new eGFR\<15mL/min/1.73m2, or * 25% decline in GFR together with a drop in GFR category, Average 4 years follow-up|Number of participants with new diagnosis of dementia, Coded dementia (ICD, Read) from linked GP and hospital data, Average 4 years follow-up|Hospitalisation with heart failure, Coded heart failure (ICD) from hospitalisation data, Average 4 years follow-up|Death due to cancer (where cancer is the underlying cause of death), Average 4 years follow-up|Major non traumatic lower limb amputation, Below or above knee amputation, coded (ICD) from hospitalisation data, Average 4 years follow-up
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