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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Recruiting

CT.gov ID

NCT04042155

Collaborator

Daiichi Sankyo, Inc. (Industry)

1,600

Enrollment

Location

36.1

Anticipated Duration (Months)

44.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Recurrent Venous Thromboembolism	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 29, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Outcome Measures

Primary Outcome Measures

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

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