Status:
TERMINATED
Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
Boehringer Ingelheim
Atrial Fibrillation Network
Conditions:
Atrial Fibrillation or Atrial Flutter
Thrombosis of Left Atrial Appendage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Detailed Description
BACKGROUND Dabigatran etexilate, a direct thrombin inhibitor and new oral anticoagulant (NOAC), has been shown to effectively prevent thromboembolic events in patients with atrial fibrillation (AF). H...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02256683
Start Date
July 1 2014
End Date
May 1 2018
Last Update
July 26 2019
Active Locations (14)
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1
University Heart Center; Department of Cardiology and Angiology II
Bad Krozingen, Germany, D-79189
2
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
3
Vivantes Clinical Center Am Urban; General Internal Medicine and conservative intensive care
Berlin, Germany, D-10967
4
Klinikum Coburg GmbH
Coburg, Germany, 96450