Rosuvastatin for Deep Vein Thrombosis

Overseen By Khanh P Nguyen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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 You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding rosuvastatin, a cholesterol-lowering medication, to standard blood-thinning treatments is safe and effective for individuals with a recent first-time deep vein thrombosis (DVT) in the leg. Researchers aim to determine if this combination can help prevent post-thrombotic syndrome, which includes long-term complications like pain and swelling, after a DVT. Suitable candidates for this trial are those who have experienced a first episode of leg DVT within the past four weeks and have not had a lung clot or previous DVT in the last two years. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that rosuvastatin is likely to be safe for humans?

Research has shown that rosuvastatin is generally safe for use. One study found that patients taking rosuvastatin experienced fewer cases of deep vein thrombosis (DVT), a type of blood clot, compared to those not taking it. Specifically, 34 patients on rosuvastatin developed DVT, while 60 patients in the comparison group did.

Another study found that rosuvastatin, also known as CRESTOR, lowered the risk of blood clots in veins by 43% compared to a placebo. These studies suggest that rosuvastatin effectively reduces blood clots and is safe, with no major side effects reported.

Although rosuvastatin is primarily used to manage cholesterol, its approval for this purpose by health authorities like the FDA supports confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for deep vein thrombosis, which typically involves anticoagulants like warfarin or direct oral anticoagulants, rosuvastatin offers a unique approach by targeting inflammation and cholesterol levels. Researchers are excited about rosuvastatin because it is primarily a statin, a type of drug known for reducing cholesterol and potentially providing additional vascular protective effects. This dual action—addressing both lipid levels and inflammation—could offer a broader benefit in managing deep vein thrombosis and reduce the risk of cardiovascular events, setting it apart from traditional blood thinners.

What evidence suggests that rosuvastatin might be an effective treatment for deep vein thrombosis?

Research has shown that rosuvastatin, the treatment under study in this trial, can help lower the risk of blood clots. One study found it reduced the risk of blood clots in veins by 43%. Another study showed a 47% reduction in individuals with heart disease risks. In a study with mice, rosuvastatin decreased inflammation after a deep vein clot, which is significant because inflammation can cause complications. Additionally, combining rosuvastatin with regular blood thinners might enhance treatment for deep vein thrombosis (DVT). These findings suggest rosuvastatin could be useful in managing DVT and preventing related issues. ^{1 3 4 5 6}

Who Is on the Research Team?

Khanh P Nguyen, MD

Principal Investigator

Portland VA Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Rosuvastatin

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 a potent statin that significantly reduces LDL cholesterol by 52-63% at doses of 10-40 mg, outperforming other statins like atorvastatin and simvastatin in lowering LDL levels.

It is well tolerated and has a safety profile similar to other statins, making it a suitable option for patients with dyslipidemia, including those with hypertriglyceridemia or diabetes.

NCBI (Pubmed)

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. Schuster, H.[2017]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8859624/

Rosuvastatin for the prevention of venous thromboembolism In this individual participant data meta-analysis, rosuvastatin reduced the risk of VTE by 47% across a pooled primary CVD prevention population with a broad ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666572725000033

The Effect of Rosuvastatin on a murine model of deep vein ... Rosuvastatin reduces C-reactive protein and cardiovascular mortality. After deep vein thrombosis (DVT), elevated inflammatory markers persist.

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-rosuvastatin-for-reducing-blood-clots-in-patients-with-deep-vein-thrombosis-or-pulmonary-embolism/

Study on Rosuvastatin for Reducing Blood Clots in Patients ... The purpose of the study is to determine if taking Rosuvastatin Calcium can lower the rate of major blood clot events in patients who have ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10440755/

The Effects of 3-Month Rosuvastatin Adjuvant Therapy on ... The results show that the addition of statins to anticoagulants seems to make the regimen more effective in improving the treatment outcomes of DVT patients.

5. dicardiology.com dicardiology.com/content/study-analysis-shows-crestor-reduces-risk-blood-clots-veins

Study Analysis Shows CRESTOR Reduces Risk of Blood ... CRESTOR (rosuvastatin calcium) 20mg significantly cut the risk of venous thromboembolism (VTE) by 43 percent (p =0.007) compared to placebo.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3338886/

Statins, inflammation and deep vein thrombosis It showed that the rate of DVT was significantly decreased in patients treated with rosuvastatin versus controls, 34 versus 60 patients respectively, with a ...