Observing real-life outcomes of direct oral anticoagulants
Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence
This study looks at how well direct oral anticoagulants work for people over 18 with atrial fibrillation or blood clots, focusing on any serious complications they might face in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT04042155 on ClinicalTrials.gov |
What this trial studies
The MACACOD study is an observational, single-center study that tracks the clinical outcomes of patients over 18 years old who are being treated with direct oral anticoagulants (DOACs) for atrial fibrillation or recurrent venous thromboembolism. It aims to assess the incidence of serious complications, such as thromboembolic or hemorrhagic events, in a real-world setting. Participants' demographic data, previous treatments, comorbidities, and baseline health metrics are recorded, and risk scores are calculated and updated throughout the study. The study also evaluates the type of health education received regarding anticoagulant therapy and estimates the costs associated with any serious complications that arise.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with atrial fibrillation or recurrent venous thromboembolism who are currently on DOAC therapy.
Not a fit: Patients with advanced cognitive impairment, psychiatric disorders, or those unable to collaborate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of DOACs in real-world clinical settings, potentially improving patient management.
How similar studies have performed: Other studies have shown success in evaluating the real-world effectiveness of anticoagulants, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona, Catalonia
- Hospital de la Santa Creu i Sant Pau — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Juan C Souto, MD, PhD — Hospital de la Santa creu i Sant Pau - Barcelona
- Study coordinator: Juan C Souto, MD, PhD
- Email: jsouto@santpau.cat
- Phone: 34-654633993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.