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Rosuvastatin for Deep Vein Thrombosis

Phase 1 & 2
Recruiting
Led By Khanh P Nguyen, MD
Research Sponsored by Khanh Nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have ECOG performance status ≤ 2
Diagnosis of a first episode of acute proximal leg DVT within 4 weeks of initial DVT diagnosis and without symptomatic pulmonary embolism (PE)
Must not have
History of active cancer or malignancy within 1 year
Limb-threatening circulatory compromise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 day
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is testing whether adding rosuvastatin to standard anticoagulation therapy is safe and effective in preventing PTS after DVT.

Who is the study for?
This trial is for men and women with a first episode of acute proximal leg DVT diagnosed within the last 4 weeks, without severe pulmonary embolism. Participants must be in relatively good health (ECOG ≤ 2), have a life expectancy over 2 years, and meet specific blood count criteria. Exclusions include pregnancy, breastfeeding, prisoners, those already in another trial or with established PTS, certain allergies or contraindications to MRI or anticoagulants.
What is being tested?
The study tests if rosuvastatin (20 mg daily) alongside standard anticoagulation therapy can improve safety and tolerability while preventing post thrombotic syndrome after a DVT event. The effectiveness of this combination treatment will be compared against the usual care for patients with lower extremity DVT.
What are the potential side effects?
Rosuvastatin may cause muscle pain or weakness, liver enzyme changes leading to potential liver damage, digestive issues like nausea or constipation, headache, dizziness and increased risk of diabetes. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I was diagnosed with a blood clot in my leg for the first time within the last 4 weeks and do not have lung complications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had any active cancer in the past year.
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My limb's blood flow is severely reduced, risking its survival.
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I have a history of unusual bleeding.
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I have had a severe lung clot affecting my heart's function.
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I am not taking any strong medication that affects how drugs are processed in my body.
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I have had serious bleeding problems, including in my stomach or brain.
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I have had more than one deep vein thrombosis.
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I am allergic to or cannot take blood thinners or specific medications.
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I have been diagnosed with post-thrombotic syndrome.
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My kidney function is severely impaired.
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I do not need urgent surgery that can't wait 3 months.
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My liver function is severely impaired.
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I have not had any active bleeding in the last 3 months.
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I have a history of chronic atrial fibrillation or stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-thrombotic syndrome
Secondary study objectives
Severity of post-thrombotic syndrome (PTS)

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630
8%
genital fungal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RosuvastatinExperimental Treatment1 Intervention
Subjects will receive 20 mg daily dose of rosuvastatin for at least 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
FDA approved

Find a Location

Who is running the clinical trial?

Khanh NguyenLead Sponsor
Khanh P Nguyen, MDPrincipal InvestigatorPortland VA Medical Center

Media Library

Rosuvastatin Clinical Trial Eligibility Overview. Trial Name: NCT04833764 — Phase 1 & 2
Post-Thrombotic Syndrome Research Study Groups: Rosuvastatin
Post-Thrombotic Syndrome Clinical Trial 2023: Rosuvastatin Highlights & Side Effects. Trial Name: NCT04833764 — Phase 1 & 2
Rosuvastatin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04833764 — Phase 1 & 2
~4 spots leftby Jun 2025
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