MACACOD is a clinical record in the usual clinical practice of direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban). Design: single-center, observational, prospective, uncontrolled study of anticoagulated patients with any direct oral anticoagulant (DOAC) with atrial fibrillation or venous thromboembolism to determine the incidence of serious complications (thromboembolic or hemorrhagic) in real life
Population: Patients over 18 years of age, with recurrent atrial fibrillation or venous thromboembolism, already anticoagulated with any DOAC or patients who initiate therapy with DOAC and who give their consent. Upon entering the study, demographic data, previous anticoagulant treatments, previous serious complications, comorbidities and baseline analytical results are recorded. The risk scores CHA2DS2-Vasc, HAS-BLED and Charlson comorbidity index (CCI) are calculated. The type of health education received in relation to anticoagulant therapy is also recorded. During the follow-up, complications and clinical changes and the analytical results of coagulation, renal and hepatic function will be recorded. The risk scores will be updated at each visit. In case of serious complications, the associated costs will be estimated.
Study Type
OBSERVATIONAL
Enrollment
1,600
Record of all serious complications associated with any of the drugs and the clinical changes that occurred during prospective follow-up.
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
RECRUITINGThromboembolic events
Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
Time frame: 3 years
Major haemorrhagic events
Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale Full scale name: Bleeding Assessment Research Consortium Scale ranges: 0-5 Where 0 is the better result and 5 is the worst
Time frame: 3 years
Other thrombotic events
Myocardial infarction, transient ischemic attack, superficial thrombophlebitis
Time frame: 3 years
Clinically (non major) relevant bleeding
Any documented bleeding event grade 2 in the Bleeding Assessment Research Consortium (BARC) scale Full scale name: Bleeding Assessment Research Consortium Scale ranges: 0-5 Where 0 is the better result and 5 is the worst
Time frame: 3 years
Mortality
Death from any cause
Time frame: 3 years
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