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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    30
  • sponsor
    Khanh Nguyen
Updated on 22 October 2021

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.

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.

Details
Condition deep venous thrombosis of lower extremity, post thrombotic syndrome, Venous stasis, Deep Vein Thrombosis Leg
Treatment Rosuvastatin
Clinical Study IdentifierNCT04833764
SponsorKhanh Nguyen
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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 aPTT40

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note