NCT04329390

MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: Quovadis Associazione · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anticoagulants and Bleeding Disorders

Interventions

Type	Name	Description
DRUG	Anticoagulant drugs	Prescription of, or already on oral anticoagulant treatment.

Timeline

• Start date: 2019-03-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-04-01
• Last updated: 2025-05-07

Locations

1 site across 1 country: Italy