Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis
- Conditions
- HypercholesterolemiaVenous Thromboembolism
- Interventions
- Behavioral: diet
- Registration Number
- NCT00437892
- Lead Sponsor
- Università degli Studi dell'Insubria
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lipid lowering diet diet - Atorvastatin and lipid lowering diet diet - Atorvastatin and lipid lowering diet atorvastatin -
- Primary Outcome Measures
Name Time Method proportion of patients with elevated D-dimer at day 90 3 months
- Secondary Outcome Measures
Name Time Method proportion of patients with elevated D-dimer levels at Day 30; 1 month proportion of patients with recurrent VTE 3 months 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
Trial Locations
- Locations (3)
University of Bologna
🇮🇹Bologna, Italy
Ospedale di Piacenza
🇮🇹Piacenza, Italy
University Of Insubria
🇮🇹Varese, Italy