Left atrial-appendage thrombus in atrial fibrillation
Conditions
Interventions
Trade Name: Pradaxa® 150 mg Hartkapseln
Product Name: Pradaxa® 150 mg Hartkapseln
Product Code: B01AE07
Pharmaceutical Form: Capsule, hard
Sponsors
University Medical Center of the Johannes Gutenberg University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
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 less than 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 during the trial and a negative pregnancy test (serum and urine) should be existent before trial onset. In case of Phenprocoumon as study medication a reliable contraception has to be continued three month after last intake of Phenprocoumon, due to the teratogenic potential of Marcumar®. Reliable contraceptive methods are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with a spermicide. Women that are sterile by surgery or for more than two years postmenopausal can participate in the trial. - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Patients > 80 years - Low body weight ( 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 (see chapter 5.2) - 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 medi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether Dabigatran leads to a faster complete LAA thrombus resolution as compared to Phenprocoumon.; Secondary Objective: To assess the impact of Dabigatran on - complete LAA thrombus resolution rate until week 6 - change in LAA thrombus size under treatment To assess and compare safety and tolerability of Dabigatran and Phenprocoumon ;Primary end point(s): Time to complete LAA thrombus resolution; Timepoint(s) of evaluation of this end point: week 3 week 4 week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Complete LAA thrombus resolution until week 6 (yes/no) - Change in LAA thrombus size under treatment - Occurrence of any adverse event - Occurrence of major bleedings (see chapter 8.9.1) - Occurrence of strokes (all-type, haemorrhagic, ischemic) ascertained by CCT or cMRT - Occurrence of TIAs - Occurrence of cardiovascular events requiring hospitalization (e.g. myocardial infarction, acute coronary syndrome, severe tachyarrhythmia) - Occurrence of other thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism) ; Timepoint(s) of evaluation of this end point: week 3 week 4 week 6 week 7 | — |
Countries
Germany
Contacts
Public ContactThomas Rostock
University Medical Center of the Johannes Gutenberg University Mainz
Outcome results
None listed