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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042155
• Other study ID #: IIBSP-ACO-2018-31
• Status: Recruiting
• Start date: July 29, 2019
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Juan C Souto, MD, PhD
• Phone: 34-654633993
• Email: jsouto[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrent Venous Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Daiichi Sankyo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolic events	Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism	3 years
Primary	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	Other thrombotic events	Myocardial infarction, transient ischemic attack, superficial thrombophlebitis	3 years
Secondary	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
Secondary	Mortality	Death from any cause	3 years