• combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications [ Time Frame: during the time of follow up (at least two years) ]
  

• frequency and duration of hospitalisation [ Time Frame: during the time of follow up (at least two years) ]
  
• mortality [ Time Frame: during the time of follow up (at least two years) ]
  
• recurrence of stroke [ Time Frame: during the time of follow up (at least two years) ]
  
• numbers of INR values above 4.5 or lower than 1.7 [ Time Frame: during the time of follow up (at least two years) ]
  
• treatment-related quality of life analysis [ Time Frame: during the time of follow up (at least two years) ]
  
• cost-effectiveness evaluations [ Time Frame: during the time of follow up (at least two years) ]
  
• median of squared INR value deviation (INR - ½(Upper Value of Target INR Range + Lower Value of Target INR Range)) [ Time Frame: during the time of follow up (at least two years) ]
  
• percentage of individual patients' INR values within the target range and the percentage of time within target range [ Time Frame: during the time of follow up (at least two years) ]
  

Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications in patients for whom it is indicated. Numerous studies have documented that elderly patients seem to benefit most from OAC therapy. Atrial fibrillation (AF), the incidence of which increases with age and approaches 10% for individuals aged ≥ 80 years, carries the main risk for stroke, and among elderly patients without antithrombotic therapy,

Despite its proven benefit, numerous studies have reported reluctance in prescribing OAC due to a variety of barriers, especially in the elderly. Risk of haemorrhage, which is in fact twice as great in those over 70 years of age as in younger patients, is one of the major determinants of refusal to prescribe OAC therapy. The risk of stroke rises steeply in patients with atrial fibrillation when INR values are less than 1.8 and INR values greater than 4 to 5 are rapidly associated with increased bleeding rates. Due to relatively small therapeutic ranges, the reality is often that only a small percentage of the INR values have been found to be within the target range, which can be low as 29% of INR measurements, as seen in routine care patients prior to participation in a randomised self-management programme study.

One way to improve OAC care is by introducing patients' self-management of OAC therapy. In this context it is important to differentiate between INR self-testing alone, and full self-management. Self-management includes self-adaptation of the anticoagulation treatment based on self-monitoring results after the patients have participated in a structured instruction and treatment programme.

Our study aims to provide answers to this important medical question by examining elderly patients receiving long-term anticoagulation treatment and randomised into self-management versus routine-care groups, with thromboembolic and haemorrhagic complications as primary outcomes.