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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Venous Thromboembolism, Hypercholesterolemia

Intervention / Treatment
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* Drug: atorvastatin
* Drug: atorvastatin
* Behavioral: diet
* Behavioral: diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin and lipid lowering diet<br> | Drug: atorvastatin<br>* tablets, 40 mg day, 3 months<br>Drug: atorvastatin<br>* tablets, 40 mg once daily<br>Behavioral: diet<br>* daily diet<br>|
| Active Comparator: lipid lowering diet<br> | Behavioral: diet<br>* daily<br>Behavioral: diet<br>* daily diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with elevated D-dimer at day 90 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with elevated D-dimer levels at Day 30; |  | 1 month | 
| 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 recurrent VTE |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statins, secondary prevention, venous thromboembolism, d-dimer