NCT00437892

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	atorvastatin	tablets, 40 mg day, 3 months
DRUG	atorvastatin	tablets, 40 mg once daily
BEHAVIORAL	diet	daily
BEHAVIORAL	diet	daily diet

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-02-21
• Last updated: 2011-08-19

Locations

3 sites across 1 country: Italy