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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence

Conditions
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Atrial Fibrillation, Recurrent Venous Thromboembolism

Intervention / Treatment
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* Drug: dabigatran, rivaroxaban, apixaban or edoxaban


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dabigatran, rivaroxaban, apixaban or edoxaban|Record of all serious complications associated with any of the drugs and the clinical changes that occurred during prospective follow-up.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic events | Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism | 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other thrombotic events | Myocardial infarction, transient ischemic attack, superficial thrombophlebitis | 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 | 3 years | 
| Mortality | Death from any cause | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dabigatran, rivaroxaban, apixaban, edoxaban