MAS
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
Sponsor study identifier
observational
2,000
1 country
1
Study Start
August 9, 2018
Actual (reported)Primary Completion
May 30, 2022
Actual (reported)Study Completion
May 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 9, 2018
Actual (reported)January 7, 2019
Actual (reported)January 14, 2019
Actual (reported)May 30, 2022
Actual (reported)May 30, 2023
Actual (reported)Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines)
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
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)
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
Number and rate of patients who discontinued treatment
From date of enrollment until the date of first documented event assessed up to 12 months
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
Sophie Testa
Cremona, 26100, Italy
Palareti G, Testa S, Legnani C, Dellanoce C, Cini M, Paoletti O, Ciampa A, Antonucci E, Poli D, Morandini R, Tala M, Chiarugi P, Santoro RC, Iannone AM, De Candia E, Pignatelli P, Faioni EM, Chistolini A, Esteban MDP, Marietta M, Tripodi A, Tosetto A. More early bleeds associated with high baseline direct oral anticoagulant levels in atrial fibrillation: the MAS study. Blood Adv. 2024 Sep 24;8(18):4913-4923. doi: 10.1182/bloodadvances.2024013126.
Testa S, Palareti G, Legnani C, Dellanoce C, Cini M, Paoletti O, Ciampa A, Antonucci E, Poli D, Morandini R, Tala M, Chiarugi P, Santoro RC, Iannone AM, De Candia E, Pignatelli P, Faioni EM, Chistolini A, Esteban MDP, Marietta M, Tripodi A, Tosetto A. Thrombotic events associated with low baseline direct oral anticoagulant levels in atrial fibrillation: the MAS study. Blood Adv. 2024 Apr 23;8(8):1846-1856. doi: 10.1182/bloodadvances.2023012408.
plasma samples
Sophie Testa, MD
UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy
2,000 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2019
First Posted
January 14, 2019
Study Start
August 9, 2018
Actual (reported)Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study
Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban
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
Contact the study team to confirm eligibility.
Primary Completion
May 30, 2022
Actual (reported)Study Completion
May 30, 2023
Actual (reported)Last Updated
July 20, 2023
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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