MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

Study Overview
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Brief Summary
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MAC Project is a prospective cohort, multicenter, observational, no-profit study aimed to prospectively collect reliable real-life clinical information in unselected VTE or NVAF patients treated with any DOAC, during a medium-long term follow-up period.

Detailed Description
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MAC Project is a prospective cohort, multicenter, observational, no-profit study aimed to prospectively collect reliable real-life clinical information in unselected VTE or NVAF patients treated with any DOAC, during a medium-long term follow-up period. Patients will be investigated in Italian hospital-based clinical centers, skilled in the management of adult patients with VTE or NVAF requiring anticoagulant treatment, and followed-up up to 5 years. The drugs will be prescribed according to current standards of care and regulations and not provided by any sponsor. The primary outcome is to collect and evaluate the safety and efficacy data of DOACs in a real-life setting, regardless of the underlying pathology, and the duration of treatment. The secondary outcome is to separately evaluate safety and efficacy of DOACs for treatment of cardiovascular diseases, specifically considering treatment duration, as follows: short-term (e.g., superficial venous thrombosis); medium-term (e.g., deep vein thrombosis, pulmonary embolism, etc.); long-term (e.g., atrial fibrillation, prevention of recurrent VTE or long-term treatment of recurrent VTE, peripheral arterial obstructive disease, etc.).Investigators will store event-driven clinical information into a REDCap based on-line EDC system about management and outcome of all efficacy and safety end-points; treatment compliance/adherence; VTE risk factors; thromboembolic and haemorrhagic risk-scores; comorbidities; concomitant treatments; patients' appreciation by a specific score (ACTS); clinical or adverse events; survival; possible causes of death.

Official Title
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MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

Conditions
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Anticoagulants and Bleeding Disorders

Intervention / Treatment
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* Drug: Anticoagulant drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged > 18 years, mandatory anticoagulant treatment ability to understand the purposes of the study ability to express valid informed consent. Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anticoagulant<br>Subjects of both sexes, aged 18 years or older, requiring the prescription of, or already on oral anticoagulant treatment, will be eligible for the study, irrespective of the index event, of the intended treatment duration, and the type of drug used. | Drug: Anticoagulant drugs<br>* Prescription of, or already on oral anticoagulant treatment.<br>* Other names: OAC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAFETY OF OAC THERAPY | incidence of major bleeding, incidence of clinically relevant non-major bleeding, incidence of minor bleeding, incidence of serious adverse events, incidence of mortality (VTE-related, cardiovascular, and all-cause). | 5 years | 
| EFFICACY OF OAC THERAPY | incidence of symptomatic recurrent VTE, incidence of symptomatic recurrent VTE in the various treatment subgroups, incidence of stroke (ischemic and haemorrhagic), incidence of systemic embolic events, number of hospital admissions related to cardiovascular (either venous or arterial) disease, incidence of post-thrombotic syndrome. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time relate outcomes | To separately evaluate safety and efficacy of DOACs for treatment of cardiovascular diseases, specifically considering treatment duration, as follows: short-term (e.g., superficial venous thrombosis); medium-term (e.g., deep vein thrombosis, pulmonary embolism, etc.); long-term (e.g., atrial fibrillation, prevention of recurrent VTE or long-term treatment of recurrent VTE, peripheral arterial obstructive disease, etc.). | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benefit-risk, anticoagulant, DOAC, OAC