MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

Anticoagulants and Bleeding Disorders Clinical Trial

— MAC  

Official title:

MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04329390
• Other study ID #: MAC Project
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2023
• Source: Quovadis Associazione
• Contact: Cristiano Bortoluzzi, MD
• Phone: +39-041763457
• Email: crisbort[@]libero.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Drug:
• Anticoagulant drugs
Prescription of, or already on oral anticoagulant treatment.

Locations

Country	Name	City	State
Italy	Giuseppe Camporese	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Quovadis Associazione

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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