Evaluating Cerebral micro-bleeding cHanges to Optimise anticoagulation thErapy in Stroke patients with Atrial Fibrillation

Exclusion Criteria18

• History of heart valve disease due to moderate-to-severe mitral stenosis or with a mechanical heart valve.
• AF/AFL due to reverse causes of cardiac surgery, pulmonary embolism, and untreated hyperthyroidism.
• Known presence of atrial myxoma, left ventricular thrombus, or active endocarditis.
• Other significant active neurological illnesses present since suffering a stroke (e.g., recurrent seizures*, multiple sclerosis, brain tumour). Well-controlled epilepsy present prior to the stroke, a single seizure at the stroke onset or provoked seizure is not an exclusion.
• Note that recurrent seizure(s) are defined as = 2 seizures that are unprovoked (i.e., not related to reversible stressors) and that occur >24 hours apart in the past three months.
• Known or detecting competing brain lesions associated with ICH predisposition except cortical superficial siderosis on brain MRI, such as neoplasm, arteriovenous malformation, cavernous hemangioma, aneurysm, and subdural haematoma.
• Has been diagnosed as having dementia on formal clinical assessment.
• Diagnosis of hypotension, defined as sitting systolic blood pressure less than 100 mmHg.
• Currently taking warfarin but cannot/unwilling to be switched to a NOAC.
• Unable to swallow tablets/capsules.
• Major cardiac surgery or transcatheter intervention within the past 2 months or planned cardiac surgery or transcatheter intervention within the next 3 months.
• Have malignancy or other serious concomitant diseases with a life expectancy of 3x upper limit of the normal range [ULN], acute clinical hepatitis, chronic active hepatitis, or cirrhosis).
• Any other conditions associated with increased bleeding risks:
• Major non-cardiac surgery within the past 2 months or planned non-cardiac surgery within the next 3 months.
• Anaemia (haemoglobin level 100 mmHg).
• Needs anticoagulant therapy for disorders other than AF.
• Any other condition, in the opinion of investigators, that renders the patient unsuitable for the trial (such as clinically significant out of the normal range of serum sodium [145 mmol/L] or potassium [5.5 mmol/L]) and would compromise adherence, safe participation, and follow-up in the trial (e.g., drug addiction, alcohol abuse, history of drug overdose or attempted suicide or significant active mental illness, moving outside or visitor to the area, etc.).
• Have other definite contradictions for NOAC (e.g., concomitant use of prohibited medications [please see 7.5.2]) and or definite indications for lower-dose NOAC (e.g., concomitant use of restricted medications).