Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon (NCT02591225) | Clinical Trial Compass
UnknownPhase 4
Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon
Germany40 participantsStarted 2015-10
Plain-language summary
This is a single-center, randomized, two treatment groups, open, phase IV clinical study in subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit) subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can be performed followed by randomization to one of the two treatment groups (Phenprocoumon or Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at this visit. If the subject was randomized in the VKA group routinely INR measurements will performed.
Who can participate
Age range
18 Years – 79 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:
* signed and dated written informed consent
* atrail fibrillation
* left atrial thrombus
* negative pregnancy test in woman with childbearin potentail
* subjects who have the ability to understand and comply the instructions for participation
Exclusion Criteria:
* low body weight \< 50 kg
* instable cardiac or respiratory condition
* contraindication for Phenprocoumon or Dabigatran
* severely reduced renal function (CrCl \< 30 ml/min)
* inadequate hepatic function (AST and ALT higher than 2 x ULN)
* Contraindication for MRI
* Durg/alcohol abusus
* Pregnant or nursing woman
* subject is an employee of any involved study investigator
* Parallel participation in another clinical trial
* Treatment with another investigational product
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.