Clinical trial NCT04329390: MAC Project, Monitoring of AntiCoagulant Therapies (MAC)
Official title: MAC Project, Monitoring of AntiCoagulant Therapies (MAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulants and Bleeding Disorders
Keywords: anticoagulant
DOAC
OAC
benefit-risk
Lead sponsor: Quovadis Associazione
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.).

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.

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

Primary outcomes:
measure: SAFETY OF OAC THERAPY
timeFrame: 5 years
measure: EFFICACY OF OAC THERAPY
timeFrame: 5 years
Secondary outcomes:
measure: Time relate outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Giuseppe Camporese
Study officials:
affiliation: Quovadis Associazione
name: Cristiano Bortoluzzi, MD
role: PRINCIPAL_INVESTIGATOR
References: