Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And Se… (NCT03803579) | Clinical Trial Compass
CompletedNot Applicable
Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)
Italy2,000 participantsStarted 2018-08-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines)
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months
2
Number and rate of patients with confirmed thromboembolic and thromboembolic-related dath
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months
3
Number and rate of death patients (overall mortality)
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months
4
Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban