Randomized, Double-blind, Double-masked Prospective Multicenter Trial to Evaluate the Efficacy and Safety of the Oral Anticoagulant Dimolegin® Compared With Low Molecular Weight Heparin (Clexane®) as a Means of Preventing VTE in Patients Undergoing Elective Endoprosthetics of Large Joints
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 8
- 主要终点
- Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death of all causes
研究概览
简要总结
This clinical study aims to evaluate the efficacy and safety of the anticoagulant Dimolegin® compared to low molecular weight heparin (Clexane®) for the prevention of venous thromboembolic events (VTE) in patients undergoing major joint (hip or knee) replacement surgery. The study will assess the incidence of VTE, VTE-related mortality, and all-cause mortality during different follow-up periods in both treatment groups. Additionally, the study will evaluate the frequency of bleeding events and the incidence, number, and characteristics of all adverse events associated with Dimolegin® and Clexane® therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and
- •Patients scheduled for unilateral elective total hip or knee arthroplasty.
- •The patient's voluntary informed consent.
- •Negative pregnancy test result (for female patients with preserved reproductive potential).
- •Patients with reproductive potential should agree to use methods of contraception according to the protocol.
排除标准
- •Surgery for an acute fracture (<4 weeks).
- •Revision or extraction arthroplasty.
- •Septic arthritis.
- •The only lower limb.
- •Increased risk of thrombosis.
- •Active bleeding or increased risk of bleeding.
- •Current coagulopathy (patient's or his relative's) or congenital thrombophilia.
- •Collection of at least one volume unit of donated blood (≥ 450 ml) or blood transfusion during the previous 12 weeks.
- •Surgery or injury during the last 90 days.
- •Diseases of the digestive system that may disrupt the absorption of the study drug.
- •Significant cardiovascular diseases currently or within 6 months prior to screening.
- •Active liver or biliary tract diseases.
- •Creatinine clearance, calculated according to the Cockcroft-Gault formula, less than 30 ml/min.
- •Positive test result for HIV, syphilis, hepatitis B and C markers.
- •The development of trophic disorders of the lower extremities that are not amenable to drug treatment.
- •Any condition in which, in the opinion of the researcher, surgical intervention or the use of anticoagulants is contraindicated.
- •Body mass index is less than 18.5 or more than 40 kg/m
- •Body weight for women is less than 45 kg, for men less than 57 kg and above 130 kg for both.
- •Systolic blood pressure > 180 mmHg and/or diastolic blood pressure >110 mmHg.
- •Hemoglobin < 105 g/l in women or < 115 g/l in men.
- •Abnormal results aboratory parameters of the coagulation system (platelets, APTT, prothrombin time, INR) beyond the limits of normal values.
- •An increase in ALT or ACT ≥ 2 times from the upper limit of normal (ULN) or total bilirubin ≥ 1.5 times from ULN.
- •Hypersensitivity or contraindications to the administration of Dimolegin®, enoxaparin sodium, unfractionated heparin or warfarin.
- •The need for constant use of parenteral or oral anticoagulants.
- •The need for continuous use of antiplatelet drugs, which cannot be discontinued at least 4 days before the start of the investigational therapy.
- •Systemic therapy with drugs with strong inducers and inhibitors of CYP3A4 and P-glycoprotein, which cannot be discontinued at least 7 days before the start of the investigational therapy.
- •Pregnant or breast-feeding women.
- •Participation in another clinical trial currently or within 90 days prior to screening.
- •Affiliation to a research center, Sponsor, or contractual research organization.
- •Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; non-compliance with the study therapy or procedures.
研究组 & 干预措施
1 (Dimolegin® Group)
Subgroup 1A (Hip Arthroplasty): Dimolegin® + placebo Clexane® for 35±2 days. Subgroup 1B (Knee Arthroplasty): Dimolegin® + placebo Clexane® for 14±1 days.
干预措施: Dimolegin (Drug)
1 (Dimolegin® Group)
Subgroup 1A (Hip Arthroplasty): Dimolegin® + placebo Clexane® for 35±2 days. Subgroup 1B (Knee Arthroplasty): Dimolegin® + placebo Clexane® for 14±1 days.
干预措施: Sodium enoxaparine placebo (Drug)
2 (Clexane® Group)
Subgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days.
干预措施: Sodium enoxaparin (Drug)
2 (Clexane® Group)
Subgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days.
干预措施: Dimolegin placebo (Drug)
结局指标
主要结局
Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death of all causes
时间窗: up to the follow-up visit (28±2 days after the end of therapy)
次要结局
- Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death due to thrombosis(up to the follow-up visit (28±2 days after the end of therapy))
- Switching to other anticoagulant therapy(up to the follow-up visit (28±2 days after the end of therapy))
- Incidence of DVT (proximal, distal)(up to the follow-up visit (28±2 days after the end of therapy))
- Incidence of non fatal PE(up to the follow-up visit (28±2 days after the end of therapy))
- Incidence of symptomatic VTE(up to the follow-up visit (28±2 days after the end of therapy))
- Death due to VTE(up to the follow-up visit (28±2 days after the end of therapy))
- Death of all causes(up to the end of therapy (for subgroup A - up to 14±1 days, for subgroup B - up to 35±2 days))