Competitive trials and slow recruitment rate

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
• Trauma,
• 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.