Clinical trial NCT04042155: Real-life Clinical Outcomes of Direct Oral Anticoagulants (MACACOD)
Official title: Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Recurrent Venous Thromboembolism
Keywords: dabigatran
rivaroxaban
apixaban
edoxaban
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2019-08-01
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under treatment with DOAC controlled at the Hospital de Sant Pau in Barcelona and in their area of influence (Primary Care Centers). These patients must be older than 18 years, with atrial fibrillation or recurrent venous thrombosis.

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Thromboembolic events
timeFrame: 3 years
measure: Major haemorrhagic events
timeFrame: 3 years
Secondary outcomes:
measure: Other thrombotic events
timeFrame: 3 years
measure: Clinically (non major) relevant bleeding
timeFrame: 3 years
measure: Mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
affiliation: Hospital de la Santa creu i Sant Pau - Barcelona
name: Juan C Souto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: