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

July 19, 2023 updated by: Arianna Anticoagulazione Foundation

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

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cremona, Italy, 26100
        • Sophie Testa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
From date of enrollment until the date of first documented event assessed up to 12 months
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
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
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
15-20 days after the enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment until the date of first documented event assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arianna Anticoagulazione Foundation

Investigators

  • Study Director: Sophie Testa, MD, UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAA O3 12-2017 (MAS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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