NCT00437892

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 19, 2011

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

February 20, 2007

Last Update Submit

August 18, 2011

Conditions

Venous ThromboembolismHypercholesterolemia

Keywords

Statinssecondary preventionvenous thromboembolismd-dimer

Outcome Measures

Primary Outcomes (1)

  • proportion of patients with elevated D-dimer at day 90

    3 months

Secondary Outcomes (3)

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

    1 month

  • 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

  • proportion of patients with recurrent VTE

    3 months

Study Arms (2)

Atorvastatin and lipid lowering diet

EXPERIMENTAL
Drug: atorvastatinBehavioral: diet

lipid lowering diet

ACTIVE COMPARATOR
Behavioral: diet

Interventions

atorvastatinDRUG

tablets, 40 mg day, 3 months

Atorvastatin and lipid lowering diet
dietBEHAVIORAL

daily

lipid lowering diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Bologna

Bologna, Italy

Location

Ospedale di Piacenza

Piacenza, Italy

Location

University Of Insubria

Varese, 21100, Italy

Location

Related 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. doi: 10.1056/NEJMoa054444.

    PMID: 17065639BACKGROUND

  • 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.

    PMID: 16961599BACKGROUND

MeSH Terms

Conditions

Venous ThromboembolismHypercholesterolemia

Interventions

AtorvastatinDiet

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Walter Ageno

    Università degli Studi dell'Insubria

    PRINCIPAL INVESTIGATOR

  • Gualtiero Palareti

    University of Bologna

    PRINCIPAL INVESTIGATOR

  • Davide Imberti

    Piacenza Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 19, 2011

Record last verified: 2011-08

Locations

IT(3)