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NCT Number: NCT03803579

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

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.

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Key information

Conditions

Atrial Fibrillation Anticoagulant-induced Bleeding Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sophie Testa

Cremona, 26100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines)

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    Fatal bleeding; Acute clinically overt bleeding;intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal will be recorded in all patients.

  2. Number and rate of patients with confirmed thromboembolic and thromboembolic-related dath

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    Cardiovascular event: transient ischemic attack, stroke. myocardial infarction; the occurrence of deep vein thrombosis with or without pulmonary embolism will be recorded in all patients.

  3. Number and rate of death patients (overall mortality)

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    Cardiovascular related death; thromboembolic related dath, bleeding-related death, cancer related death will be recorded in all patients

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

    Time frame: 15-20 days after the enrollment

    Blood sampling is performed at trough level for each anticoagulant drug used after the last dose intake of dabigatran, apixaban, rivaroxaban and edoxaban

Secondary outcomes

  1. Number and rate of patients who discontinued treatment

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    The treatment withdrawal, either for patients or for physician decision-making will be recorded in all patients

Sponsors and collaborators

Lead sponsor

Arianna Anticoagulazione Foundation

Other

Registry information

Official study 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

Acronym: MAS

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jan 14, 2019
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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