search
Back to results

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

Primary Purpose

Venous Thromboembolism, Hypercholesterolemia

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
atorvastatin
atorvastatin
diet
diet
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Statins, secondary prevention, venous thromboembolism, d-dimer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Bologna
  • Ospedale di Piacenza
  • University Of Insubria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atorvastatin and lipid lowering diet

lipid lowering diet

Arm Description

Outcomes

Primary Outcome Measures

proportion of patients with elevated D-dimer at day 90

Secondary Outcome Measures

proportion of patients with elevated D-dimer levels at Day 30;
proportion of patients with elevated D-dimer levels at Day 0 and subsequent normalization of D-dimer levels at Day 30 and Day 90;
proportion of patients with recurrent VTE

Full Information

First Posted
February 20, 2007
Last Updated
August 18, 2011
Sponsor
Università degli Studi dell'Insubria
search

1. Study Identification

Unique Protocol Identification Number
NCT00437892
Brief Title
Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis
Official Title
The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Competitive trials and slow recruitment rate
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Hypercholesterolemia
Keywords
Statins, secondary prevention, venous thromboembolism, d-dimer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin and lipid lowering diet
Arm Type
Experimental
Arm Title
lipid lowering diet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
tablets, 40 mg day, 3 months
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
tablets, 40 mg once daily
Intervention Type
Behavioral
Intervention Name(s)
diet
Intervention Description
daily
Intervention Type
Behavioral
Intervention Name(s)
diet
Intervention Description
daily diet
Primary Outcome Measure Information:
Title
proportion of patients with elevated D-dimer at day 90
Time Frame
3 months
Secondary Outcome Measure Information:
Title
proportion of patients with elevated D-dimer levels at Day 30;
Time Frame
1 month
Title
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
Title
proportion of patients with recurrent VTE
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ageno
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gualtiero Palareti
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Davide Imberti
Organizational Affiliation
Piacenza Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bologna
City
Bologna
Country
Italy
Facility Name
Ospedale di Piacenza
City
Piacenza
Country
Italy
Facility Name
University Of Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17065639
Citation
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. doi: 10.1056/NEJMoa054444. Erratum In: N Engl J Med. 2006 Dec 28;355(26):2797.
Results Reference
background
PubMed Identifier
16961599
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. doi: 10.1111/j.1538-7836.2006.02030.x. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs