Status:
UNKNOWN
Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis
Lead Sponsor:
Khanh Nguyen
Conditions:
Post-thrombotic Syndrome
Deep Vein Thrombosis Leg
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 (Facto...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04833764
Start Date
June 1 2021
End Date
June 1 2025
Last Update
October 15 2021
Active Locations (1)
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1
VA Portland Health Care System (VAPORHCS)
Portland, Oregon, United States, 97239