Post-thrombotic SyndromePhase 1/2NCT04833764
Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis
A Phase 1/2 study testing Rosuvastatin in people with Post-thrombotic Syndrome and Deep Vein Thrombosis Leg, run by Khanh Nguyen at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-thrombotic Syndrome, Deep Vein Thrombosis Leg
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Portland Health Care System (VAPORHCS)
Portland, Oregon, 97239
About this study
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.
Read the 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
- Being tested
- Rosuvastatin
- Keywords
- Contact pathway inhibition, Coagulation factor XI inhibition, Anticoagulant, Deep vein thrombosis, Venous thrombosis
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Oral administration of 20 mg rosuvastatin for at least 3 months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Subjects will receive 20 mg daily dose of rosuvastatin for at least 3 months Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 365 day
Secondary outcomes (1)
Severity of post-thrombotic syndrome (PTS)
Villalta score severity of post-thrombotic syndrome
Measured: 365 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thrombotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khanh Nguyen
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Khanh Nguyen, Portland VA Medical Center
- Investigators
- Khanh P Nguyen, MD, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833764
- Sponsor's protocol ID
- eIRB19051/M4069
- Status last verified
- Oct 2021
- First submitted
- 2 Apr 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis
- ClinicalTrials.gov ID
- NCT04833764
- Acronym / sponsor ID
- eIRB19051/M4069
- Conditions
- Post-thrombotic Syndrome, Deep Vein Thrombosis Leg
- Keywords
- Contact pathway inhibition, Coagulation factor XI inhibition, Anticoagulant, Deep vein thrombosis, Venous thrombosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Khanh NguyenUS federal agency
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: RosuvastatinSubjects will receive 20 mg daily dose of rosuvastatin for at least 3 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinOral administration of 20 mg rosuvastatin for at least 3 months | Drug | Rosuvastatin |
Primary outcome
Post-thrombotic syndrome
Time frame: 365 day
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.
1 secondary outcome
Severity of post-thrombotic syndrome (PTS)
Time frame: 365 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khanh P Nguyen, MD principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rosuvastatin in people with Post-thrombotic Syndrome and Deep Vein Thrombosis Leg, run by Khanh Nguyen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khanh P Nguyen, MD (5034947145, nguykha@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-thrombotic syndrome (time frame: 365 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.