Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF
Status:
Terminated
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess whether Dabigatran leads to a faster
complete left atrial appendage (LAA) thrombus resolution as compared to Phenprocoumon. The
secondary objectives of this trial are to assess the impact of Dabigatran versus
Phenprocoumon on complete LAA thrombus resolution rate until week 6 and change in LAA
thrombus volume under treatment as well as to assess and compare safety and tolerability of
both drugs. A total of 110 patients with atrial fibrillation and LAA thrombus will be
randomized to receive either Dabigatran (150 mg bid) or Phenprocoumon (INR 2-3) for a least
three weeks. Thrombus resolution will be determined by transoesophageal echocardiography
(TEE) 3 weeks after start of study treatment and subsequently at week 4 and 6 if necessary,
i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the
resolution of the LAA thrombus. For those patients whose thrombus still exists after 6 weeks
treatment, the study is also terminated. Further treatments will be decided at the discretion
of the treating physician.
Phase:
Phase 2
Details
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborators:
Atrial Fibrillation Network Boehringer Ingelheim German Atrial Fibrillation Network