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

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ClinicalTrials.gov Identifier: NCT00437892
Recruitment Status : Terminated (Competitive trials and slow recruitment rate)
First Posted : February 21, 2007
Last Update Posted : August 19, 2011
Sponsor:
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Hypercholesterolemia Drug: atorvastatin Behavioral: diet Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event
Study Start Date : May 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. proportion of patients with elevated D-dimer at day 90 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. proportion of patients with elevated D-dimer levels at Day 30; [ Time Frame: 1 month ]
  2. 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 ]
  3. proportion of patients with recurrent VTE [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437892


Locations
Italy
University of Bologna
Bologna, Italy
Ospedale di Piacenza
Piacenza, Italy
University Of Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Walter Ageno Università degli Studi dell'Insubria
Principal Investigator: Gualtiero Palareti University of Bologna
Principal Investigator: Davide Imberti Piacenza Hospital

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
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: August 2011

Keywords provided by Walter Ageno, Università degli Studi dell'Insubria:
Statins
secondary prevention
venous thromboembolism
d-dimer

Additional relevant MeSH terms:
Hypercholesterolemia
Thromboembolism
Venous Thromboembolism
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Fibrin fragment D
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants