- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042155
Real-life Clinical Outcomes of Direct Oral Anticoagulants (MACACOD) (MACACOD)
February 27, 2024 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juan C Souto, MD, PhD
- Phone Number: 34-654633993
- Email: jsouto@santpau.cat
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Time Frame: 3 years
|
Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
|
3 years
|
Major haemorrhagic events
Time Frame: 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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other thrombotic events
Time Frame: 3 years
|
Myocardial infarction, transient ischemic attack, superficial thrombophlebitis
|
3 years
|
Clinically (non major) relevant bleeding
Time Frame: 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
|
3 years
|
Mortality
Time Frame: 3 years
|
Death from any cause
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Juan C Souto, MD, PhD, Hospital de la Santa creu i Sant Pau - Barcelona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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