Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Khanh Nguyen

Code:

NCT04833764

Conditions

Post-thrombotic Syndrome

Deep Vein Thrombosis Leg

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rosuvastatin

Study Details

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 (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.

Conditions

Post-thrombotic Syndrome

Deep Vein Thrombosis Leg

Study ID

NCT04833764

Start date

Jun 1, 2021

Status verified date

Oct, 2021

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Rosuvastatin

Subjects will receive 20 mg daily dose of rosuvastatin for at least 3 months

Interventions

Rosuvastatin

Oral administration of 20 mg rosuvastatin for at least 3 months

Primary outcome measure

  • Post-thrombotic syndrome [ Time Frame: 365 day ]

Central Contacts and Locations

Central contacts

Khanh P Nguyen, MD

5034947145nguykha@ohsu.edu

Tahnee Groat, MPH

503-220-8262groat@ohsu.edu

Locations

VA Portland Health Care System (VAPORHCS)

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Khanh Nguyen

Last update posted

Oct 15, 2021

Last verified

Oct, 2021

Keywords

  • Contact pathway inhibition
  • Coagulation factor XI inhibition
  • Anticoagulant
  • Deep vein thrombosis
  • Venous thrombosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Khanh Nguyen on 2021-10-15.