Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS) (MAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03803579|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 5, 2020
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|
|Atrial Fibrillation Anticoagulant-induced Bleeding|
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|
|Estimated Enrollment :||4000 participants|
|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 :||August 9, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||August 2022|
- 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.
- 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.
- 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
- 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
- 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
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803579
|Contact: Michela Cini, BSc||0039 firstname.lastname@example.org|
|Contact: Cristina Legnani, BSc||0039 email@example.com|
|Cremona, Italy, 26100|
|Study Director:||Sophie Testa, MD||UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy|