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

NCT03803579 | Completed

• 1 other identifier: FAA O3 12-2017 (MAS)
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Anticoagulant-induced Bleeding

Keywords

Atrial Fibrillation; Bleeding event; Thromboembolic event; Plasma concentration of drug

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (1)

• Number and rate of patients who discontinued treatment

  From date of enrollment until the date of first documented event assessed up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arianna Anticoagulazione Foundation: lead

Study Sites (1)

Sophie Testa

Cremona, 26100, Italy

Location

Related Publications (2)

• 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.

  PMID: 38842448 DERIVED

• 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.

  PMID: 38394387 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

Atrial Fibrillation; Thromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Sophie Testa, MD

  UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 14, 2019
• Study Start: August 9, 2018
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IT (1)