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Venous ThromboembolismPhase 2NCT00437892

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

A Phase 2 study testing atorvastatin and diet in people with Venous Thromboembolism and Hypercholesterolemia, run by Università degli Studi dell'Insubria at 3 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism, Hypercholesterolemia
What is being tested?
atorvastatin and diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesItaly
Study dates
May 2007to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 17Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • University of Bologna

    Bologna

  • Ospedale di Piacenza

    Piacenza

  • University Of Insubria

    Varese, 21100

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
atorvastatin, diet
Keywords
Statins, secondary prevention, venous thromboembolism, d-dimer
Medical subject headings
Venous Thromboembolism, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atorvastatinDrug

    tablets, 40 mg day, 3 months

  • atorvastatinDrug

    tablets, 40 mg once daily

  • dietBehavioural

    daily

  • dietBehavioural

    daily diet

Study groups in NCT00437892
Study groupRoleWhat they receive
Atorvastatin and lipid lowering dietExperimentalNot described
Receives: Drug: atorvastatin; Behavioral: diet
lipid lowering dietActive comparatorNot described
Receives: Behavioral: diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of patients with elevated D-dimer at day 90

    Measured: 3 months

Secondary outcomes (3)

  1. proportion of patients with elevated D-dimer levels at Day 30;

    Measured: 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;

    Measured: 3 months

  3. proportion of patients with recurrent VTE

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2011
  4. Study completionMay 2011

Why it stopped: Competitive trials and slow recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00437892
Sponsor's protocol ID
7948
Status last verified
Aug 2011
First submitted
20 Feb 2007
Last updated
19 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17065639

  • 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.

    PubMed 16961599

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing atorvastatin and diet in people with Venous Thromboembolism and Hypercholesterolemia, run by Università degli Studi dell'Insubria at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Competitive trials and slow recruitment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of patients with elevated D-dimer at day 90 (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00437892, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.

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