Clinical trial NCT03803579: Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)
Official title: Baseline DOAC Measurement in Non Valvular Atrial Fibrillation Patients and Incidence of Bleeding or Thromboembolic Complications During Follow-up: a Prospective, Multicenter, Observational Study. The MAS (Measure And See) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Anticoagulant-induced Bleeding
Keywords: Atrial Fibrillation
Bleeding event
Thromboembolic event
Plasma concentration of drug
Lead sponsor: Arianna Anticoagulazione Foundation
Sponsor class: OTHER
First posted: 2019-01-14
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: 4000 consecutive Non Valvular Atrial Fibrillation outpatients, 1000 for each single drug, aged \>18 years and 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

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines)
timeFrame: From date of enrollment until the date of first documented event assessed up to 12 months
measure: Number and rate of patients with confirmed thromboembolic and thromboembolic-related dath
timeFrame: From date of enrollment until the date of first documented event assessed up to 12 months
measure: Number and rate of death patients (overall mortality)
timeFrame: From date of enrollment until the date of first documented event assessed up to 12 months
measure: Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban
timeFrame: 15-20 days after the enrollment
Secondary outcomes:
measure: Number and rate of patients who discontinued treatment
timeFrame: From date of enrollment until the date of first documented event assessed up to 12 months
Other outcomes:
Locations:
city: Cremona
country: Italy
facility: Sophie Testa
Study officials:
affiliation: UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy
name: Sophie Testa, MD
role: STUDY_DIRECTOR
References: