Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis (NCT04833764) | Clinical Trial Compass
UnknownPhase 1/2
Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis
United States30 participantsStarted 2021-06-01
Plain-language 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 (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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-G…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.