EUCTR2005-001999-12-ES进行中（未招募）1 期
Estudio aleatorizado en fase III, doble ciego, en grupos paralelos, de la eficacia y la seguridad de etexilato de dabigatrán (150 mg bid) por vía oral, en comparación con warfarina (INR 2,0-3,0) para el tratamiento durante 6 meses del tromboembolismo venoso sintomático agudo, después del tratamiento inicial (5-10 días) con un anticoagulante parenteral aprobado para esta indicación. RE-COVER - RE-COVER
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
- 2,550
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. Acute symptomatic uni- or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) confirmed by definitive objective clinical test in patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the investigator
- •2. Male or female, being 18 years of age or older
- •3. 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. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
- •2. PE satisfying at least one of the following criteria:
- •? Haemodynamic instability
- •? Embolectomy is indicated or performed
- •? Thrombolytic therapy is indicated or performed
- •? Suspected source of PE is other than the legs
- •3. Actual or anticipated use of vena cava filter
- •4. Contraindications to anticoagulant therapy including contraindications to heparins or other alternate approved therapy used for initial treatment, and warfarin
- •5. Patients who in the investigator’s opinion should not be treated with warfarin
- •6. Allergy to heparins (including history of heparin induced thrombocytopenia) or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
- •7. Patients who in the investigator’s judgement are perceived as having an excessive risk of bleeding, for example because of:
- •? Hemorrhagic disorder or bleeding diathesis
- •? Trauma or major surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned major surgery
- •? Any of the following intracranial pathologies: neoplasm, arteriovenous malformation or aneurysm
- •? History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra articular bleeding
- •? Gastrointestinal haemorrhage within the past 3 months
- •? Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
- •? Treatment with thrombolytic agents within 14 days before enrolment
- •? Anticipated need of restricted medication during the treatment period
- •(see CTP Section 4.2.2)
- •? Known thrombocytopenia (platelet count < 100•109•L-1)
- •8. Known anaemia (haemoglobin < 100 g•L-1)
- •9. Need of anticoagulant treatment for disorders other than VTE
- •10. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrolment (investigator’s judgement), acute bacterial endocarditis or history of myocardial infarction within the last 3 months
- •11. Elevated AST or ALT > 2x ULN based on the local lab results obtained at screening and prior to randomisation (or central screening lab if available on time)
- •12. Liver disease expected to have any potential impact on survival (e.g. acute hepatitis, possibly active hepatitis B, hepatitis C or cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery)
- •13. Patients who have developed transaminase elevations upon exposure to ximelagatran
- •14. Severe renal impairment (estimated creatinine clearance = 30 ml/min)
- •15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (NOTE: A negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study)
- •16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
- •17. Patients considered unsuitable for inclusion by the investigator, e.g. because considered unreliable to comply with the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
- •18. In case of anticipated study related diagnostic procedures requir
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