Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)
NCT ID: NCT03803579
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2000 participants
OBSERVATIONAL
2018-08-09
2023-05-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Arianna Anticoagulazione Foundation
OTHER
Responsible Party
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Principal Investigators
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Sophie Testa, MD
Role: STUDY_DIRECTOR
UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy
Locations
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Sophie Testa
Cremona, , Italy
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FAA O3 12-2017 (MAS)
Identifier Type: -
Identifier Source: org_study_id
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