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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other thrombotic events | Myocardial infarction, transient ischemic attack, superficial thrombophlebitis | 3 years |
| Clinically (non major) relevant bleeding | 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 |
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Inclusion Criteria:
· Patients older than 18 years.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan C Souto, MD, PhD | Contact | 34-654633993 | jsouto@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Juan C Souto, MD, PhD | Hospital de la Santa creu i Sant Pau - Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Catalonia | 08025 | Spain |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| C552171 | edoxaban |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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Plasma samples remaining from the routine blood tests.
| 3 years |
| Mortality | Death from any cause | 3 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |