Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)

Arianna Anticoagulazione Foundation

Status: Completed

Conditions: Atrial Fibrillation; Anticoagulant-induced Bleeding

Study type: Observational

Funder types: Other

Identifiers

NCT03803579

FAA O3 12-2017 (MAS)

Details and patient eligibility

About

The MAS Study is an observational, multicentre, prospective cohort study in Non valvular Atrial fibrillation (NVAF) patients treated with one of the direct oral anticoagulants (DOACs) available in Italy for NVAF patients.

The general aim is to deepen the knowledge of DOAC treatment in NVAF patients, by measuring the plasma concentration of anticoagulant drugs and their correlation with any adverse events that may occur during treatment.

Full 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.

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

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NVAF patients starting DOAC anticoagulation
• age > 18 years
• ability to give written informed consent
• availability, as part of the normal withdrawals, to the blood sampling for the study purpose
• availability for 12-months follow-up

Exclusion criteria

• age < 18 years
• indication for electrical cardioversion at the moment of drug prescription
• participation in Phase II or III clinical trials
• indication for treatment different from NVAF
• not suitable to give or not giving informed consent
• not available for blood collection or follow-up

Trial design