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

Sponsor

Arianna Anticoagulazione Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT03803579

Collaborator

(none)

4,000

Enrollment

Location

54.7

Anticipated Duration (Months)

73.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Anticoagulant-induced Bleeding

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 Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 9, 2018

Actual Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines) [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.
Number and rate of patients with confirmed thromboembolic and thromboembolic-related dath [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.
Number and rate of death patients (overall mortality) [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
Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban [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 Outcome Measures

Number and rate of patients who discontinued treatment [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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