Status:
TERMINATED
Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Venous Thromboembolism
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 r...
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 plan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00437892
Start Date
May 1 2007
End Date
May 1 2011
Last Update
August 19 2011
Active Locations (3)
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1
University of Bologna
Bologna, Italy
2
Ospedale di Piacenza
Piacenza, Italy
3
University Of Insubria
Varese, Italy, 21100