A Multinational, Multicentre, Randomized, Open, Parallel Group Study on the Efficacy and Safety of Bemiparin Sodium (LMWH) Compared to Enoxaparin Sodium (LMWH) in the Treatment of Acute Deep Vein Thrombosis (DVT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 25
- 主要终点
- Percentage of patients with an improvement in thrombotic burden at Visit 3
研究概览
简要总结
Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when a thrombus forms in one of the large veins, usually in the lower limbs, leading to either partial or complete blocked circulation. The condition may progress to severe health complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and effective manner.
The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and pulmonary embolism in the short term and to prevent recurrent events in the long-term. Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also increases the risk for major hemorrhage.
This trial aims to optimize the current medical knowledge on the effectiveness and safety of two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein thrombosis.
详细描述
The aim of this study is to demonstrate the therapeutic non-inferiority of bemiparin sodium (LMWH) versus enoxaparin sodium (LMWH) during a 7±2 days treatment period and a follow up of 11 weeks observation period.
Primary endpoint:
The percentage of patients with an improvement in thrombotic burden at Visit 3 (Day 83) defined as a ≥4-point reduction in thrombus score (or at least halving the thrombus score, when the total score is ≤ 6), without confirmed symptomatic extension of recurrence of DVT, confirmed symptomatic PE, or VTE-related death at Visit 3 (Day 83 / Month 3), as measured by complete compression ultrasound (cCUS) by Duplex sonography according to a standardized protocol.
Secondary endpoint:
The secondary efficacy endpoints are defined as the:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute deep-vein thrombosis of the leg (DVT) with symptoms of less than 14 days confirmed by complete compression ultrasound (cCUS) within 48 h prior study starting .
- •Males and females aged ≥18 years
- •Patients who have given their written informed consent.
排除标准
- •History and presence of familial bleeding diathesis, presence of active bleeding contraindicating anticoagulant therapy, as well as presence of clinically relevant coagulation - and clotting factor disorder,and thrombocytopenia
- •Patients having undergone thrombectomy, having had insertion of a caval filter or who were treated with a fibrinolytic agent to treat the current episode of DVT
- •Treatment with heparin (fractionated or unfractionated), fondaparinux or vitamin K antagonist or warfarin for treatment of DVT for more than 48 h prior to enrolment
- •Long-term treatment with vitamin K antagonists, i.e. for atrial fibrillation, myocardial infarction or cardiomyopathy
- •Isolated distal calf vein thrombosis
- •Isolated superficial vein thrombosis
- •Any other symptomatic venous thromboembolism beside of DVT
- •Known hypersensitivity to heparin (including other pig-derived substances), to the study medications and heparin-derivatives including other LMWHs, warfarin and/or to the active ingredient or any excipient of the study medications
- •Concurrent treatment with platelet function inhibitors (such as acetylsalicylic acid, ticlopidine, clopidogrel, NSAID), fibrinolytic agents and other anticoagulant agents, Glycoprotein IIb/IIIa receptor- antagonists, nitro-glycerine iv, systemic glucocorticoids, penicillin in high doses, dextran, ascorbic acid, digitalis, tetracycline, medical products that could increase the potassium plasma level
- •History of documented or suspected heparin-induced thrombocytopenia (HIT I and II) or platelet count less than 100,000 platelets per mm3
- •Ischaemic stroke one month prior to enrolment
- •History of or active intracranial disorder (cerebral vascular aneurysm, arterio-venous malformation or cerebral neoplasm), history of haemorrhagic stroke or other intracranial bleeding 6 months prior to enrolment, active haemorrhage or increased risk of bleeding due to impaired haemostatics or organ lesion (e.g. peptic ulcer, hepatic failure, haemorrhagic stroke, macroscopic visible urogenital bleeding, cerebral vascular aneurysm or cerebral neoplasm) 1 month prior to enrolment.
- •Uncontrolled arterial hypertension: systolic blood pressure > 200 mmHg and diastolic blood pressure > 105 mmHg.
- •Severe impairment of pancreas function, history of gastro-duodenal ulcer disease, nephrolithiasis and/or ureterolithiasis, choroid and retinal vascular disease, suspected vascular retinopathy, vitreous haemorrhage or other intraocular bleedings, or any organic lesion with an increased risk of bleeding.
- •Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, hepatic cirrhosis, hepatic encephalopathy) or liver enzymes (ALT and/or AST) > 5x ULN.
研究组 & 干预措施
Enoxaparin sodium
subcutaneous for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin
干预措施: Enoxaparin sodium (Drug)
Bemiprin sodium
Bemiparin sodium (LMWH) s.c. for 7±2 days and starting on Day 2 additionally the oral anticoagulant warfarin
干预措施: Bemiparin sodium (Drug)
结局指标
主要结局
Percentage of patients with an improvement in thrombotic burden at Visit 3
时间窗: 83±7 days
次要结局
- Incidence of symptomatic venous thromboembolic events (VTE)(83±7 days)