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

Completed

• Conditions: Anticoagulant-induced Bleeding; Atrial Fibrillation

• Registration Number: NCT03803579
• Lead Sponsor: Arianna Anticoagulazione Foundation

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.

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 Timeline

• Study Start: 2018-08-09
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Primary Completion: 2022-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sophie Testa; 🇮🇹 Cremona, Italy