Clinical trial NCT00437892: Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis
Official title: The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Venous Thromboembolism
Hypercholesterolemia
Keywords: Statins
secondary prevention
venous thromboembolism
d-dimer
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of patients with elevated D-dimer at day 90
timeFrame: 3 months
Secondary outcomes:
measure: proportion of patients with elevated D-dimer levels at Day 30;
timeFrame: 1 month
measure: proportion of patients with elevated D-dimer levels at Day 0 and subsequent normalization of D-dimer levels at Day 30 and Day 90;
timeFrame: 3 months
measure: proportion of patients with recurrent VTE
timeFrame: 3 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
city: Piacenza
country: Italy
facility: Ospedale di Piacenza
city: Varese
country: Italy
facility: University Of Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Walter Ageno
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: Gualtiero Palareti
role: PRINCIPAL_INVESTIGATOR
affiliation: Piacenza Hospital
name: Davide Imberti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palareti G, Cosmi B, Legnani C, Tosetto A, Brusi C, Iorio A, Pengo V, Ghirarduzzi A, Pattacini C, Testa S, Lensing AW, Tripodi A; PROLONG Investigators. D-dimer testing to determine the duration of anticoagulation therapy. N Engl J Med. 2006 Oct 26;355(17):1780-9. doi: 10.1056/NEJMoa054444.
citation: Squizzato A, Romualdi E, Ageno W. Why should statins prevent venous thromboembolism? A systematic literature search and a call for action. J Thromb Haemost. 2006 Sep;4(9):1925-7. doi: 10.1111/j.1538-7836.2006.02030.x. No abstract available.