Real-life Clinical Outcomes of Direct Oral Anticoagulants (MACACOD)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Enrolling

Conditions

Atrial Fibrillation

Recurrent Venous Thromboembolism

Treatments

Drug: dabigatran, rivaroxaban, apixaban or edoxaban

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04042155

IIBSP-ACO-2018-31

Details and patient eligibility

About

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

Full description

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.

Enrollment

1,600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

· Patients older than 18 years.