Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis

Hypercholesterolemia Clinical Trial

Official title: The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Thromboembolism
• Venous Thromboembolism

• NCT number: NCT00437892
• Study type: Interventional
• Source: Università degli Studi dell'Insubria
• Status: Terminated
• Phase: Phase 2
• Start date: May 2007
• Completion date: May 2011