Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT00437892
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00437892
Study Brief:
Protocol Section:
NCT00437892