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

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04042155

Acronym

MACACOD

Enrollment

1600

Registered

2019-08-01

Start date

2019-07-29

Completion date

2024-08-31

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Recurrent Venous Thromboembolism

Keywords

dabigatran, rivaroxaban, apixaban, edoxaban

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.

Interventions

DRUGdabigatran, 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Spain

Contacts

Primary ContactJuan C Souto, MD, PhD

jsouto@santpau.cat34-654633993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026