Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF (RE-LATED_AF)

This is an interventional treatment trial for Atrial Fibrillation or Atrial Flutter focused on measuring atrial fibrillation, atrial flutter, Atrial-Appendage Thrombus, Thrombus resolution, Dabigatran, Phenprocoumon, Transesophageal Echocardiography Read More

Inclusion Criteria:

• Patients with documented non-valvular AF or atrial flutter (12-lead ECG)
• Newly diagnosed or confirmed LAA thrombus in TEE (time of detection ≤ 28 days)
• Patients 18 years old
• CHA2DS2-VASc Score 1
• CrCL 30 mL/min (Cockcroft-Gault)
• Women with childbearing potential have to practice a medically accepted contraception
• Ability of patient to understand the character and the individual consequences of the clinical trial
• Signed and dated informed consent before start of any specific trial procedures

Exclusion Criteria:

• Patients > 80 years
• Low body weight (< 50 kg)
• Previous failure of LAA thrombus resolution with a VKA or factor Xa antagonist
• Occurrence of LAA thrombus under long-term treatment (> 3 months) with vitamin K antagonists with an exception in the case of continued INR out of the target range
• Contraindications for oral anticoagulation therapy (see current Fachinformation for Pradaxa® (150 mg) and Marcumar® (3 mg))
• History of heart valve disorder (i.e., prosthetic valve or hemodynamically relevant valve disease)
• Valvular heart disease requiring intervention (including mechanical valves)
• Acute myocardial infarction or MI within the last 26 weeks
• Acute coronary syndrome (e.g. instable angina pectoris, STEMI, NSTEMI)
• Chronic Heart Failure (> NYHA IIIa)
• Previous haemorrhagic stroke
• TIA within the last 90 days
• Clinical relevant bleeding within the last 26 weeks
• Acute and subacute bacterial endocarditis
• Recurrent pulmonary embolism
• Esophagitis, gastritis and gastroesophageal reflux
• Thrombocytopenia or functional platelet defects
• Congenital or acquired coagulation or haemorrhagic disorders
• Liver diseases (liver enzymes >2 ULN)
• Renal insufficiency (CrCL below 30 mL/min)
• Pre-treatment with Dabigatran in doses higher than 110 mg bid
• Concomitant treatment with rivaroxaban, apixaban, and in case of approval during the course of the trial, also edoxaban
• Concomitant treatment with irreversible cyclooxygenase inhibitors (e.g. ASA) at doses > 100 mg/d.
• Concomitant treatment with high doses of Adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel) at doses > 75 mg/d
• Combined treatment with Adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel) and irreversible cyclooxygenase inhibitors (e.g. ASA) in any dose combination
• Planned treatment with long-term oral anticoagulants for alternative indications
• Concomitant treatment with P-glycoprotein (P-gp) inhibitors, i.e. verapamil.
• Need for continued treatment with ticlopidine, ticagrelor, prasugrel, systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic/myelosuppressive therapy
• Concomitant treatment with medication not permitted
• Planned surgical intervention during expected study participation or previous surgical interventions within the last 30 days
• Other significant risk factors for bleeding complications (e.g. malignancy)
• Pregnancy and lactation.
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Participation in other clinical trials during the present clinical trial or within the last 90 days.
• Medical or psychological condition that would not permit completion of the trial or signing of informed consent.