CompletedNot Applicable

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

Italy2,000 participantsStarted 2018-08-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

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

Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban

Timeframe: 15-20 days after the enrollment

Trial details

NCT IDNCT03803579

SponsorArianna Anticoagulazione Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-30

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban

Timeframe: 15-20 days after the enrollment