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

Khanh Nguyen

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Post-thrombotic Syndrome

Deep Vein Thrombosis Leg

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04833764

eIRB19051/M4069

Details and patient eligibility

About

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.

Full description

Post-thrombotic syndrome (PTS) is a significant complication that occurs up to 75% of patients after DVT. Rosuvastatin is a HMGCoA reductase inhibitor that has anti-inflammatory effects. In this study, the investigators will evaluate the safety and tolerability of combination standard anticoagulation therapy (e.g. Factor Xa inhibitor, rivaroxaban, apixaban) and three months of 20 mg dose of rivaroxaban and its efficacy as prophylaxis against PTS after lower extremity DVT. After the diagnosis of lower extremity DVT with either duplex venous ultrasound or other imaging, study participants will initiate standard rivaroxaban therapy as per standard medical care. All consented participants in this trial will receive three months of rosuvastatin (20 mg daily dose). Assessment of post thrombotic syndrome follow up will continue for 365 days from the time of DVT diagnosis or until resolution or stabilization of any clinically significant drug related adverse event, after which they will be considered off-study.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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)