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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2022
  • participants needed
    4000
  • sponsor
    Arianna Anticoagulazione Foundation
Updated on 25 March 2021
anticoagulants
fibrillation
anticoagulation therapy

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.

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

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding
Clinical Study IdentifierNCT03803579
SponsorArianna Anticoagulazione Foundation
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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