RECRUITING

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

Conditions

Post-thrombotic Syndrome Deep Vein Thrombosis Leg Contact pathway inhibition Coagulation factor XI inhibition Anticoagulant Deep vein thrombosis Venous thrombosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-01

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04833764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Khanh P Nguyen, MD

CONTACT

5034947145

nguykha@ohsu.edu

Tahnee Groat, MPH

CONTACT

503-220-8262

groat@ohsu.edu

Principal Investigator

Khanh P Nguyen, MD

PRINCIPAL_INVESTIGATOR

Portland VA Medical Center

Study Locations (Sites)

VA Portland Health Care System (VAPORHCS)

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Khanh Nguyen

Khanh P Nguyen, MD, PRINCIPAL_INVESTIGATOR, Portland VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Post-thrombotic Syndrome
Deep Vein Thrombosis Leg