Rosuvastatin for Deep Vein Thrombosis

Overseen by Khanh P Nguyen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Khanh Nguyen

Must be taking: Factor Xa inhibitors

Must not be taking: P-GP, CYP3A4 inhibitors

Disqualifiers: Prior DVT, PTS, Cancer, others

Stay on Your Current Meds

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking certain medications like P-GP or strong CYP3A4 inhibitors or inducers. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Rosuvastatin for Deep Vein Thrombosis?

Research shows that Rosuvastatin, a drug used to lower cholesterol, also reduces the risk of blood clots in veins, known as venous thromboembolism, in people at risk of heart disease. This suggests it might help with conditions like Deep Vein Thrombosis, which involves similar blood clotting issues. ^{1 2 3 4 5}

Is rosuvastatin generally safe for humans?

Rosuvastatin (Crestor) has been studied for its effects on cholesterol and cardiovascular health, showing it can significantly lower cholesterol levels. However, there is limited evidence from small trials about its safety, and more research is needed to fully understand its safety profile. ^{1 3 4 6 7}

How does the drug rosuvastatin differ from other treatments for deep vein thrombosis?

Rosuvastatin is unique because it not only lowers cholesterol but also has anti-inflammatory effects, which may help reduce the risk of blood clots like deep vein thrombosis. Unlike other treatments that primarily focus on thinning the blood, rosuvastatin's ability to lower inflammation and cholesterol could offer additional benefits in preventing clot formation. ^{1 2 3 4 5}

Research Team

Khanh P Nguyen, MD

Principal Investigator

Portland VA Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Before starting blood thinning medication, your blood clotting tests must show normal results: INR should be 1.5 or less, and aPTT should be 40 or less.

You are expected to live for more than 2 years.

You need to have enough platelets in your blood before starting anticoagulation: Platelet count should be more than 100 billion per liter.

Exclusion Criteria

I have not had any active cancer in the past year.

My limb's blood flow is severely reduced, risking its survival.

You cannot have an MRI scan because you have metal implants or feel very scared in small, enclosed spaces.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard anticoagulation therapy and 20 mg daily dose of rosuvastatin for 3 months

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessment of post-thrombotic syndrome

365 days

Treatment Details

Interventions

• Rosuvastatin (Statins)

Trial Overview 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.

Participant Groups

Group I: Rosuvastatin Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Khanh Nguyen

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

In the JUPITER trial, rosuvastatin significantly reduced the occurrence of major cardiovascular events in healthy individuals aged ≥60 years (women) or ≥50 years (men) with normal LDL-C levels but elevated hsCRP levels, demonstrating its efficacy in primary prevention of cardiovascular disease.

Rosuvastatin was well tolerated, with most side effects being mild to moderate, and it effectively lowered both LDL-C and hsCRP levels, although the exact mechanism of its benefits remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin: a review of its use in the prevention of cardiovascular disease in apparently healthy women or men with normal LDL-C levels and elevated hsCRP levels. Carter, NJ.[2015]

Rosuvastatin is an effective statin that significantly improves lipid profiles in patients with dyslipidemias, outperforming other statins like atorvastatin, pravastatin, and simvastatin in achieving LDL-C goals after 12 weeks of treatment.

The treatment is generally well tolerated, with low incidences of serious side effects, such as myopathy and elevated CPK levels, making rosuvastatin a safe first-line option for managing cholesterol in both low- and high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin: a review of its use in the management of dyslipidemia. Scott, LJ., Curran, MP., Figgitt, DP.[2018]

In a study of 502 patients with primary hypercholesterolemia, rosuvastatin (5 mg and 10 mg) significantly reduced LDL cholesterol levels by 42% and 49%, respectively, outperforming pravastatin and simvastatin, which reduced LDL-C by 28% and 37%.

Rosuvastatin 10 mg achieved National Cholesterol Education Program (NCEP) treatment goals in 87% of patients, demonstrating its superior efficacy compared to pravastatin (53%) and simvastatin (64%), while all treatments were well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. Paoletti, R., Fahmy, M., Mahla, G., et al.[2019]

Rosuvastatin is a highly potent statin that effectively inhibits cholesterol synthesis, showing up to a 65% reduction in LDL cholesterol in hypercholesterolemic patients during early-phase studies.

The drug selectively targets liver cells with minimal uptake in nonhepatic tissues, and it has low potential for metabolic interactions, making it a safe option for lipid-lowering therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the pharmacology of statins: characteristics of rosuvastatin. Chapman, MJ., McTaggart, F.[2019]

Rosuvastatin, currently in phase III clinical trials, shows promise in significantly lowering total cholesterol and LDL cholesterol levels in patients with high cholesterol, potentially more effectively than other statins.

However, there is not enough evidence to assess the safety of rosuvastatin or its impact on heart-related health outcomes, indicating that further research is needed to fully understand its benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin: do we need another statin? Ho, C.[2010]

Rosuvastatin (Crestor) is more effective than other statins in lowering low-density lipoprotein cholesterol (LDL-C), showing greater reductions across doses of 5-40 mg/day, and also increases high-density lipoprotein cholesterol while significantly reducing triglycerides.

In clinical trials, rosuvastatin was well tolerated with a low incidence of adverse events, demonstrating a safety profile similar to other statins, although long-term safety and effectiveness in preventing coronary events have not been established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin: a high-potency HMG-CoA reductase inhibitor. Lopez, LM.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Rosuvastatin: a review of its use in the prevention of cardiovascular disease in apparently healthy women or men with normal LDL-C levels and elevated hsCRP levels. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Rosuvastatin: a review of its use in the management of dyslipidemia. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing the pharmacology of statins: characteristics of rosuvastatin. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Rosuvastatin--a highly effective new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor: review of clinical trial data at 10-40 mg doses in dyslipidemic patients. [2017]

6. Canada pubmed.ncbi.nlm.nih.gov

Rosuvastatin: do we need another statin? [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Rosuvastatin: a high-potency HMG-CoA reductase inhibitor. [2019]