MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

NCT ID: NCT04329390

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

anticoagulant

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.

Anticoagulant drugs

Intervention Type: DRUG

Prescription of, or already on oral anticoagulant treatment.

Interventions

Anticoagulant drugs

Prescription of, or already on oral anticoagulant treatment.

Intervention Type: DRUG

Other Intervention Names

OAC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quovadis Associazione

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristiano Bortoluzzi, MD

Role: PRINCIPAL_INVESTIGATOR

Quovadis Associazione

Locations

Giuseppe Camporese

Padua, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

MAC Project

Identifier Type: -

Identifier Source: org_study_id