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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-05-31

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.

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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.

Conditions

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Venous Thromboembolism Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin and lipid lowering diet

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

tablets, 40 mg day, 3 months

atorvastatin

Intervention Type DRUG

tablets, 40 mg once daily

diet

Intervention Type BEHAVIORAL

daily diet

lipid lowering diet

Group Type ACTIVE_COMPARATOR

diet

Intervention Type BEHAVIORAL

daily

diet

Intervention Type BEHAVIORAL

daily diet

Interventions

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atorvastatin

tablets, 40 mg day, 3 months

Intervention Type DRUG

atorvastatin

tablets, 40 mg once daily

Intervention Type DRUG

diet

daily

Intervention Type BEHAVIORAL

diet

daily diet

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No