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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2022
  • participants needed
    1600
  • sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Updated on 24 January 2021
anticoagulants
rivaroxaban
thromboembolism
apixaban
edoxaban
dabigatran

Summary

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

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.

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia, Recurrent Venous Thromboembolism
Treatment dabigatran, rivaroxaban, apixaban or edoxaban
Clinical Study IdentifierNCT04042155
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients older than 18 years
With atrial fibrillation or recurrent venous thrombosis
In chronic treatment with any DOAC type drug
Patients who sign the informed consent

Exclusion Criteria

Patients who do not guarantee collaboration
Patients with advanced cognitive impairment and not supervised
Patients with alcoholism
Patients with psychiatric disorder and not supervised
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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