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临床试验/EUCTR2013-005364-26-DE
EUCTR2013-005364-26-DE进行中（未招募）1 期

Resolution of Left Atrial-Appendage Thrombus – Effects of Dabigatran in patients with AF (RE-LATED AF) – A Prospective, multicenter, randomized, open-label, controlled, explorative, blinded-endpoint (PROBE) trial to compare the efficacy of Dabigatran (150 mg bid) with Phenprocoumon for the resolution of left atrial appendage thrombus formation in patients with atrial fibrillation - RE-LATED-AF

niversity Medical Center of the Johannes Gutenberg University Mainz0 个研究点目标入组 110 人开始时间: 2014年4月28日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
110
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • •- 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

排除标准

  • •- 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 (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

研究者

发起方
niversity Medical Center of the Johannes Gutenberg University Mainz

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