Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anticoagulant-induced Bleeding
- Atrial Fibrillation
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The MAS Study is an observational, prospective cohort study, double blind, multicentre, international and no Profit. Anticoagulation clinics, affiliated or not to the Italian FCSA, will be asked to take an active part in the study, provided they have the facilities for blood sampling and processing....
The MAS Study is an observational, prospective cohort study, double blind, multicentre, international and no Profit. Anticoagulation clinics, affiliated or not to the Italian FCSA, will be asked to take an active part in the study, provided they have the facilities for blood sampling and processing. 4000 consecutive NVAF outpatients, 1000 for each single drug, starting anticoagulation with one of the four DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) will be enrolled at the moment of the first prescription. Patients will receive the type and dosage of DOAC on the base of clinical characteristics at the discretion of the attending physician, as the normal clinical practice, and the study will not influence the decision of the type and dosage of DOAC. The primary study objective is to evaluate the possible relationship between DOAC anticoagulant levels at the trough, measured at steady state (within the first 2-4 weeks of treatment) and occurrence of bleeding and thromboembolic events during the subsequent one year follow up
Tracking Information
- NCT #
- NCT03803579
- Collaborators
- Not Provided
- Investigators
- Study Director: Sophie Testa, MD UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy