NCT04042155

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Recurrent Venous Thromboembolism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-29
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2019-08-01
• Last updated: 2024-02-28

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study