Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism Hypercholesterolemia |
Drug: atorvastatin Behavioral: diet |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event |
- proportion of patients with elevated D-dimer at day 90 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- proportion of patients with elevated D-dimer levels at Day 30; [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- proportion of patients with elevated D-dimer levels at Day 0 and subsequent normalization of D-dimer levels at Day 30 and Day 90; [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- proportion of patients with recurrent VTE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Atorvastatin and lipid lowering diet |
Drug: atorvastatin
tablets, 40 mg day, 3 months
Drug: atorvastatin
tablets, 40 mg once daily
Behavioral: diet
daily diet
|
| Active Comparator: lipid lowering diet |
Behavioral: diet
daily
Behavioral: diet
daily diet
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Italy | |
| University of Bologna | |
| Bologna, Italy | |
| Ospedale di Piacenza | |
| Piacenza, Italy | |
| University Of Insubria | |
| Varese, Italy, 21100 | |
| Principal Investigator: | Walter Ageno | Università degli Studi dell'Insubria |
| Principal Investigator: | Gualtiero Palareti | University of Bologna |
| Principal Investigator: | Davide Imberti | Piacenza Hospital |
More Information
Publications:
| Responsible Party: | Walter Ageno, Associate Professor of Internal Medicine, Università degli Studi dell'Insubria |
| ClinicalTrials.gov Identifier: | NCT00437892 History of Changes |
| Other Study ID Numbers: | 7948 |
| Study First Received: | February 20, 2007 |
| Last Updated: | August 18, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Università degli Studi dell'Insubria:
|
Statins secondary prevention venous thromboembolism d-dimer |
Additional relevant MeSH terms:
|
Hypercholesterolemia Thromboembolism Venous Thrombosis Venous Thromboembolism Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Thrombosis Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013