Resolution of Left Atrial-Appendage thrombus - Effects of Dabigatran in patients with AF (RE-LATED AF)
Laufzeit: 01.01.2013 - 31.12.2018
Kurzfassung
Patients with AF require at least temporarily anticoagulant treatment when presenting a LAA thrombus, but usually they need a long-term anticoagulation therapy. Treatment of patients with VKAs substantially reduces the risk of thromboembolism, but is associated with a risk of bleeding and additional treatment challenges, such as slow onset of action, multiple drug-drug and food interactions, the requirement for regular INR-monitoring and dose adjustment during treatment. In addition,...Patients with AF require at least temporarily anticoagulant treatment when presenting a LAA thrombus, but usually they need a long-term anticoagulation therapy. Treatment of patients with VKAs substantially reduces the risk of thromboembolism, but is associated with a risk of bleeding and additional treatment challenges, such as slow onset of action, multiple drug-drug and food interactions, the requirement for regular INR-monitoring and dose adjustment during treatment. In addition, continued effective anticoagulation with VKAs may not prevent thromboembolic events in patients with permanent AF and prevalent LA thrombi.
Due to its fast onset of action and low intra-individual variability of drug action, the hypothesis of this trial is that Dabigatran will lead to a faster complete LAA thrombus resolution than Phenprocoumon. Therefore, the primary objective of this study is to assess whether Dabigatran leads to faster complete LAA thrombus resolution as compared to Phenprocoumon. 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.» weiterlesen» einklappen