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

Recruiting

• Conditions: Atrial Fibrillation; Recurrent Venous Thromboembolism

• Registration Number: NCT04042155
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study Start: 2019-07-29
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thromboembolic events	3 years	Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
Major haemorrhagic events	3 years	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

Secondary Outcome Measures

Name	Time	Method
Other thrombotic events	3 years	Myocardial infarction, transient ischemic attack, superficial thrombophlebitis
Mortality	3 years	Death from any cause
Clinically (non major) relevant bleeding	3 years	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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain