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

NCT04042155 | Recruiting FDA Drug

• 1 other identifier: IIBSP-ACO-2018-31
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Recurrent Venous Thromboembolism

Keywords

dabigatran; rivaroxaban; apixaban; edoxaban

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Other thrombotic events

  3 years

• Clinically (non major) relevant bleeding

  3 years

• Mortality

  3 years

Interventions

dabigatran, rivaroxaban, apixaban or edoxaban DRUG

Record of all serious complications associated with any of the drugs and the clinical changes that occurred during prospective follow-up.

Also known as: Pradaxa, Xarelto, Eliquis or Lixiana

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• · 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

You may not qualify if:

• Patients who do not guarantee collaboration.
• Patients with advanced cognitive impairment and not supervised.
• Patients with alcoholism.
• Patients with psychiatric disorder and not supervised

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples remaining from the routine blood tests.

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism

Interventions

Dabigatran; Rivaroxaban; apixaban; edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Juan C Souto, MD, PhD

  Hospital de la Santa creu i Sant Pau - Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Souto, MD, PhD

CONTACT

34-654633993; jsouto@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: July 29, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)