Long-Term Oral Anticoagulated Patients Clinical Trial
Official title:
Impact of Self-Management of Oral Anticoagulation in the Elderly in Terms of Mortality and Morbidity: a Randomized Controlled Trial - SPOG 60+
Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC).
However, no study has yet assessed the safety and efficacy of OAC self-management in elderly
patients with major thromboembolic and haemorrhagic complications as primary outcomes.
In this multi-centre, open, randomised controlled trial, patients aged 60 years or will be
randomised into a self-management or routine care group and followed up for at least two
years.
The primary hypothesis of the study is that self-management of oral anticoagulation is
superior compared to routine control in terms of reducing thromboembolic events requiring
hospitalisation and all major bleeding complications as the primary endpoint.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care