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

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.

Study Overview

• Status: Recruiting
• Conditions: Anticoagulants and Bleeding Disorders
• Intervention / Treatment: Drug: Anticoagulant drugs

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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35138
    • Recruiting
    • Giuseppe Camporese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Setting: clinical centers, either hospital-based or outpatient clinics, experienced in the management of patients with cardiovascular diseases requiring anticoagulant treatment, either on short- (e.g., superficial venous thrombosis), medium- (e.g., deep-vein thrombosis, pulmonary embolism, acute coronary syndrome, etc.), and long-term (e.g., atrial fibrillation, mechanic heart valves, secondary prevention of recurrent VTE, obstructive arterial disease of the lower limbs, etc.).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Anticoagulant drugs; Prescription of, or already on oral anticoagulant treatment.; Other Names: OAC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Quovadis Associazione

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: anticoagulant; DOAC; OAC; benefit-risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Anticoagulants
• Other Study ID Numbers: MAC Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No