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

Atrial Fibrillation Clinical Trial

— MAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803579
• Other study ID #: FAA O3 12-2017 (MAS)
• Status: Completed
• Start date: August 9, 2018
• Est. completion date: May 30, 2023

Study information

• Verified date: July 2023
• Source: Arianna Anticoagulazione Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Atrial Fibrillation
• Hemorrhage

Locations

Country	Name	City	State
Italy	Sophie Testa	Cremona

Sponsors (1)

Lead Sponsor	Collaborator
Arianna Anticoagulazione Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number and rate of patients who discontinued treatment	The treatment withdrawal, either for patients or for physician decision-making will be recorded in all patients	From date of enrollment until the date of first documented event assessed up to 12 months