Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.