Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis

Description

The goal of this study is to determine the safety and tolerability or efficacy of adjunctive treatments (including rosuvastatin 20 mg daily) in combination with standard anticoagulation therapy (Factor Xa inhibitors) in patients with lower extremity deep vein thrombosis (DVT). The efficacy of adjunctive treatments to prevent the development of post thrombotic syndrome (PTS) after DVT will be evaluated.

Conditions

Post-thrombotic Syndrome, Deep Vein Thrombosis Leg

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Study Overview

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Study Details

Study overview

The goal of this study is to determine the safety and tolerability or efficacy of adjunctive treatments (including rosuvastatin 20 mg daily) in combination with standard anticoagulation therapy (Factor Xa inhibitors) in patients with lower extremity deep vein thrombosis (DVT). The efficacy of adjunctive treatments to prevent the development of post thrombotic syndrome (PTS) after DVT will be evaluated.

Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis

Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis

Condition
Post-thrombotic Syndrome
Intervention / Treatment

-

Contacts and Locations

Portland

VA Portland Health Care System (VAPORHCS), Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men and women
  • * Diagnosis of a first episode of acute proximal leg DVT within 4 weeks of initial DVT diagnosis and without symptomatic pulmonary embolism (PE)
  • * Must have ECOG performance status ≤ 2
  • * Expected life expectancy of \>2 years
  • * Before initiation of anticoagulation, must have adequate platelet count: Platelet count \> 100 x 10\^9/L,
  • * Before initiation of anticoagulation, must have adequate hemoglobin (Hgb) count: Hgb \> 9 mg/DL
  • * Before initiation of anticoagulation, must have normal INR and PTT: INR ≤ 1.5 and aPTT≤40
  • * Concurrent participation in another therapeutic clinical trial
  • * History of prior DVT in the previous 2 years
  • * Recurrent deep vein thrombosis (DVT)
  • * Established post thrombotic syndrome (PTS)
  • * Limb-threatening circulatory compromise
  • * Pulmonary embolism with hemodynamic compromise
  • * Deranged baseline coagulation profile before initiation of anticoagulation: INR \> 1.5 or aPTT prolonged \>40
  • * Active bleeding within last 3 months
  • * Anemia with Hemoglobin\<9 mg/dL
  • * Thrombocytopenia with platelets \< 100,000/ml
  • * Previously documented hypersensitivity to either the drug or excipients
  • * Any contraindication to anticoagulation or allergy to factor V inhibitors or ferumoxytol
  • * Any contraindication to magnetic resonance imaging (MRI) including metal implants or claustrophobia
  • * Severe hepatic impairment as defined by Childs-Pugh Class B or C
  • * Severe renal impairment with CrCl\<30 ml/min,
  • * Taking any P-GP or strong CYP3A4 inhibitors or inducers
  • * History of major bleeding including history of gastrointestinal bleeding or intracranial bleeding
  • * Known history of bleeding diathesis
  • * History of chronic atrial fibrillation or stroke
  • * History of active cancer or malignancy within 1 year,
  • * Life expectancy \<2 years.
  • * Patients requiring emergent or urgent surgery or procedures within the first 3 months of the study that cannot be postponed will be excluded.
  • * Patients who are breastfeeding or anticipate pregnancy
  • * Participant is pregnant or breastfeeding
  • * Participant is a prisoner (protected population)

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Khanh Nguyen,

Khanh P Nguyen, MD, PRINCIPAL_INVESTIGATOR, Portland VA Medical Center

Study Record Dates

2025-06-01