UnknownPhase 4

Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Russia40 participantsStarted 2016-06-29

Plain-language summary

The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.

Who can participate

Age range

18 Years – 75 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: * mitral valve disease; * atrial fibrillation; * mitral valve prosthetic replacement with concomitant Cox-Maze Procedure; * 18-75 years of age; * signed informed consent form. Exclusion Criteria: * mechanical valve replacement; * repeated mitral valve surgery; * coronary artery hemodynamically significant stenoses; * ventricular arrhythmias; * creatinine clearance \<50 ml/min; * HAS-BLED score \>3; * previous stroke or transient ischemic attack; * liver diseases; * neoplasia; * pregnancy; * simultaneous antiplatelet therapy; * allergic reactions on Dabigatran or Warfarin; * cognitive disorders.

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

Thrombosis

Timeframe: 1 year

Trial details

NCT IDNCT03183843

SponsorResearch Institute for Complex Problems of Cardiovascular Diseases, Russia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-30

View on ClinicalTrials.gov More Mitral Valve Stenosis and Insufficiency trials

Who can participate

Age range

18 Years – 75 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.