EUCTR2005-001998-10-GB进行中（未招募）1 期
A phase III, randomized, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran etexilate administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous for 12 – 15 days in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery - RE-MOBILIZE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1.Patients scheduled to undergo a primary, unilateral elective total knee replacement
- •2.Male or female 18 years of age or older
- •3.Patients weighing at least 40 kg
- •4.Written informed consent prior to the start of study participation.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of bleeding diathesis
- •2.Constitutional or acquired coagulation disorders that in the investigator’s judgment puts the patient at excessive risk for bleeding
- •3.Major surgery or trauma (e.g. hip fracture) within the last 3 months
- •4.Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator’s judgment) or history of myocardial infarction within the last 3 months
- •5.Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic.
- •Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery.
- •6.Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm
- •7.History of VTE still requiring specific treatment
- •8.Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months
- •9.Gastric or duodenal ulcer within the last year
- •10.Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery)
- •11.Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment
- •12.Known severe renal insufficiency (CrCl < 30 mL/min).
- •In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.
- •13.Elevated creatinine, which in the investigator’s opinion contraindicates venography
- •14.Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin > 160 mg/day or NSAID with t½ > 12 hours within 7 days prior to knee replacement surgery or anticipated need during the study treatment period (COX-2 selective inhibitors are allowed)
- •15.Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb
- •16.Pre-menopausal women (last menstruation ?1 year prior to signing informed consent) who:
- •a)are pregnant
- •b)are nursing
- •c)are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include Intra Uterine Device (IUD), oral, implantable, patch or injectable contraceptives and surgical sterility.
- •17.Known allergy to radio opaque contrast media
- •18.History of thrombocytopenia (including heparin induced thrombocytopenia) or a platelet count < 100,000 cells/microliter at visit 1
- •19.Allergy to heparins or dabigatran
- •20.Active malignant disease or current cytostatic treatment
- •21.Participation in a clinical trial during the last 30 days
- •22.Leg amputee
- •23.Known alcohol or drug abuse which would interfere with completion of the study
- •24.Contraindications to enoxaparin
- •25.Previous participation in this st
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