Clinical trial
Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence
Name
IIBSP-ACO-2018-31
Description
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
Trial arms
Trial start
2019-07-29
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Recruiting
Treatment
dabigatran, rivaroxaban, apixaban or edoxaban
Record of all serious complications associated with any of the drugs and the clinical changes that occurred during prospective follow-up.
Other names:
Pradaxa, Xarelto, Eliquis or Lixiana
Size
1600
Primary endpoint
Thromboembolic events
3 years
Major haemorrhagic events
3 years
Eligibility 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples remaining from the routine blood tests.'}, 'enrollmentInfo': {'count': 1600, 'type': 'ESTIMATED'}}
Updated at
2024-02-28
1 organization
1 product
2 indications
Product
DabigatranIndication
Atrial FibrillationIndication
Recurrent Venous Thromboembolism