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

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ClinicalTrials.gov Identifier: NCT03803579
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
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

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Study Type : Observational
Estimated 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 : August 9, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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
plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803579


Contacts
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Contact: Michela Cini, BSc 0039 0512812339 m.cini@fondazioenarianna.org
Contact: Cristina Legnani, BSc 0039 0512812339 c.legnani@fondazionearianna.org

Locations
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Italy
Sophie Testa Recruiting
Cremona, Italy, 26100
Sponsors and Collaborators
Arianna Anticoagulazione Foundation
Investigators
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Study Director: Sophie Testa, MD UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy
  Study Documents (Full-Text)

Documents provided by Arianna Anticoagulazione Foundation:
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Responsible Party: Arianna Anticoagulazione Foundation
ClinicalTrials.gov Identifier: NCT03803579    
Other Study ID Numbers: FAA O3 12-2017 (MAS)
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arianna Anticoagulazione Foundation:
Atrial Fibrillation
Bleeding event
Thromboembolic event
Plasma concentration of drug
Additional relevant MeSH terms:
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Atrial Fibrillation
Hemorrhage
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes