MAC Project, Monitoring of AntiCoagulant Therapies (MAC)

NCT04329390 | Completed

• 1 other identifier: MAC Project
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulants and Bleeding Disorders

Keywords

anticoagulant; DOAC; OAC; benefit-risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time relate outcomes

  5 years

Study Arms (1)

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

Interventions

Anticoagulant drugs DRUG

Prescription of, or already on oral anticoagulant treatment.

Also known as: OAC

anticoagulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.).

You may qualify if:

• aged \> 18 years,
• mandatory anticoagulant treatment
• ability to understand the purposes of the study
• ability to express valid informed consent.

You may not qualify if:

• none

Sponsors & Collaborators

• Quovadis Associazione: lead

Study Sites (1)

Giuseppe Camporese

Padua, 35138, Italy

Location

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Cristiano Bortoluzzi, MD

  Quovadis Associazione

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: April 1, 2020
• Study Start: March 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)