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

NCT04833764 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: eIRB19051/M4069
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post-thrombotic syndrome

  Incidence of post-thrombotic syndrome as measured by the Villalta Scale (score = or \> 4). Minimum score=0, Maximum score=33, and a higher score indicates worse outcome.

  365 day

Secondary Outcomes (1)

• Severity of post-thrombotic syndrome (PTS)

  365 day

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

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

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Oral administration of 20 mg rosuvastatin for at least 3 months

Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Khanh Nguyen: lead

Study Sites (1)

VA Portland Health Care System (VAPORHCS)

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Khanh P Nguyen, MD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khanh P Nguyen, MD

CONTACT

5034947145; nguykha@ohsu.edu

Tahnee Groat, MPH

CONTACT

503-220-8262; groat@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective, single arm Phase 1/Phase 2 study of patients with lower extremity DVT. Phase 1 will assess safety and tolerability of xisomab 3G3 in patients with lower extremity DVT on standard rivaroxaban therapy in 12-18 subjects. Three doses of xisomab 3G3 (42, 126, or 252 mg IV) will be tested to determine the maximum tolerated dose (MTD) with the dose limiting toxicity as any major bleeding or serious adverse event. Phase 2 will assess the efficacy of xisomab 3G3 for the prevention of PTS and compare the 1 year incidence of PTS as determined by the Villalta score in patients with lower extremity DVT on standard rivaroxaban therapy in 30 study participants.

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 6, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)