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

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Recurrent Venous Thromboembolism
• Intervention / Treatment: Drug: dabigatran, rivaroxaban, apixaban or edoxaban

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 Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Juan C Souto, MD, PhD; Phone Number: 34-654633993; Email: jsouto@santpau.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Recruiting
      • Hospital de la Santa Creu i Sant Pau
      • Contact: Juan C Souto, MD, PhD; Phone Number: 34-654633993; Email: jsouto@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients under treatment with DOAC controlled at the Hospital de Sant Pau in Barcelona and in their area of influence (Primary Care Centers). These patients must be older than 18 years, with atrial fibrillation or recurrent venous thrombosis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Daiichi Sankyo
• Investigators: Principal Investigator: Juan C Souto, MD, PhD, Hospital de la Santa creu i Sant Pau - Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: rivaroxaban; apixaban; edoxaban; dabigatran
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban; Edoxaban
• Other Study ID Numbers: IIBSP-ACO-2018-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No