MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

Quovadis Associazione

Status: Completed

Conditions: Anticoagulants and Bleeding Disorders

Treatments: Drug: Anticoagulant drugs

Study type: Observational

Funder types: Other

Identifiers

NCT04329390

MAC Project

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

anticoagulant

Description:

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.

Treatment:

Drug: Anticoagulant drugs