The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- proportion of patients with elevated D-dimer at day 90
研究概览
简要总结
Elevated levels of D-dimer, a marker of procoagulant state, have been identified as a marker of an increased risk of recurrent VTE. Statins have proven antithrombotic properties, as suggested by the reduction of several prothrombotic markers, including D-dimer, in patients at high risk of arterial thrombosis. Such antithrombotic properties could also be observed in patients at high risk of venous thrombosis. Aim of the study is to assess the effect of statins on D-dimer levels in patients with previous VTE after oral anticoagulant treatment withdrawal.
详细描述
Patients with a single episode of idiopathic VTE (either DVT or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with LDL cholesterol levels of equal to or greater than 130 mg/dL will be randomized to either atorvastatin, 40 mg, 1 tablet daily and lipid lowering diet or lipid lowering diet for 3 months. On the day of oral anticoagulant treatment withdrawal (Day 0), enrolled patients will undergo measurement of plasma D-dimer. At 30 days ± 3 (Day 30), patients will undergo measurement of D-dimer, CK, LDH, ALAT e ASAT and clinical evaluation. At 90 days ± 7 (Day 90), patients will undergo measurement of D-dimer, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides ed clinical evaluation, CK, LDH, ALAT e ASAT. At 6 months ± 1 (Day 180), patients will undergo clinical evaluation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a single episode of idiopathic VTE (either DVT or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with LDL cholesterol levels of equal to or greater than 130 mg/dL.
排除标准
- •Age below 18 years,
- •Pregnancy or puerperium,
- •Active malignancy,
- •Need for other anticoagulant treatments (unfractionated heparin, low molecular weight heparin),
- •Presence of transient risk factors for VTE [recent (< 3 months) surgery,
- •Fractures,
- •Acute medical disease with immobilization,
- •Pregnancy or use of oral contraceptives],
- •Contraindications to statin therapy,
- •Chronic renal failure (defined by creatinine clearance < 30 mL/min),
- •Ongoing treatment with statins or fibrates,
- •Major indication to statin therapy [history of cardiovascular disease, diabetes, elevated cardiovascular risk according to the ATP III criteria(19)],
- •Life expectancy of less than 6 months,
- •Geographic inaccessibility,
- •Concomitant enrolment in another clinical trial,
- •Refused informed consent.
研究组 & 干预措施
Atorvastatin and lipid lowering diet
干预措施: atorvastatin (Drug)
Atorvastatin and lipid lowering diet
干预措施: diet (Behavioral)
lipid lowering diet
干预措施: diet (Behavioral)
结局指标
主要结局
proportion of patients with elevated D-dimer at day 90
时间窗: 3 months
次要结局
- proportion of patients with elevated D-dimer levels at Day 0 and subsequent normalization of D-dimer levels at Day 30 and Day 90;(3 months)
- proportion of patients with elevated D-dimer levels at Day 30;(1 month)
- proportion of patients with recurrent VTE(3 months)
研究者
Walter Ageno
Associate Professor of Internal Medicine
Università degli Studi dell'Insubria