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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00437892
• Other study ID #: 7948
• Status: Terminated
• Phase: Phase 2
• First received: February 20, 2007
• Last updated: August 18, 2011
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• atorvastatin
tablets, 40 mg day, 3 months
• atorvastatin
tablets, 40 mg once daily

Behavioral:
• diet
daily
• diet
daily diet

Locations

Country	Name	City	State
Italy	University of Bologna	Bologna
Italy	Ospedale di Piacenza	Piacenza
Italy	University Of Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. Erratum in: N Engl J Med. 2006 Dec 28;355(26):2797. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with elevated D-dimer at day 90		3 months	No
Secondary	proportion of patients with elevated D-dimer levels at Day 30;		1 month	No
Secondary	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	No
Secondary	proportion of patients with recurrent VTE		3 months	Yes