EUCTR2004-001317-34-CZ进行中（未招募）不适用
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. - RE-MODEL (Thromboembolism prevention after knee surgery)
Boehringer Ingelheim Pharma Ges mbH0 个研究点目标入组 2,010 人开始时间: 2005年1月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,010
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
- 性别
- All
入选标准
- •1. Patients scheduled to undergo a primary, unilateral elective total knee replacement
- •2. Male or female being 18 years or older
- •3. Patients weighing at least 40 kg
- •4. Written informed consent for 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 judgement 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 enrolment (investigator’s judgement) or history of myocardial infarction within the last 3 months
- •5. Spinal or epidural anaesthesia, for which more than 3 attempts at placement were made (sticks), or the placement was traumatic.
- •6. Any history of haemorrhagic 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 enrolment
- •12. Known severe renal insufficiency (CrCl < 30 ml/min).
- •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 17. Known allergy to radio opaque contrast media
- •18. History of thrombocytopenia (incl. 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 study or RE-NOVATE or RE-MOBILIZE
研究者
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