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

NCT ID: NCT04833764

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-06-01

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.

Detailed 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.

Conditions

Post-thrombotic Syndrome; Deep Vein Thrombosis Leg

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

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

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Oral administration of 20 mg rosuvastatin for at least 3 months

Interventions

Rosuvastatin

Oral administration of 20 mg rosuvastatin for at least 3 months

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khanh Nguyen

FED

Sponsor Role: lead

Responsible Party

Khanh Nguyen

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Khanh P Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Portland VA Medical Center

Locations

VA Portland Health Care System (VAPORHCS)

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Khanh P Nguyen, MD

Role: CONTACT

nguykha@ohsu.edu

5034947145

Tahnee Groat, MPH

Role: CONTACT

groat@ohsu.edu

503-220-8262 ext. 56888

Other Identifiers

eIRB19051/M4069

Identifier Type: -

Identifier Source: org_study_id