Investigating treatments for deep vein thrombosis and post-thrombotic syndrome

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

This study is testing if adding a cholesterol-lowering medication called rosuvastatin to standard blood thinners can help prevent post-thrombotic syndrome in people with deep vein thrombosis.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Portland VA Medical Center (fed)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT04833764 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of combining rosuvastatin with standard anticoagulation therapy in patients diagnosed with lower extremity deep vein thrombosis (DVT). Participants will receive standard treatment with Factor Xa inhibitors, such as rivaroxaban, alongside a daily dose of rosuvastatin for three months. The primary focus is to assess whether this combination can prevent the development of post-thrombotic syndrome (PTS), a common complication following DVT. Follow-up assessments will occur over a year to monitor outcomes related to PTS and any adverse effects from the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with a first episode of acute proximal leg DVT within the last four weeks and without symptomatic pulmonary embolism.

Not a fit: Patients with a history of recurrent DVT or established post-thrombotic syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of post-thrombotic syndrome in patients with DVT.

How similar studies have performed: While there have been studies on anticoagulation therapies for DVT, the specific combination of rosuvastatin with Factor Xa inhibitors for preventing PTS is relatively novel.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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)

Where this trial is running

Portland, Oregon

• VA Portland Health Care System (VAPORHCS) — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Khanh P Nguyen, MD — Portland VA Medical Center
• Study coordinator: Khanh P Nguyen, MD

Conditions: Post-thrombotic Syndrome, Deep Vein Thrombosis Leg, Contact pathway inhibition, Coagulation factor XI inhibition, Anticoagulant, Deep vein thrombosis, Venous thrombosis