Statins to Prevent Cancer-Associated Blood Clots

This study is looking at whether a common cholesterol-lowering medicine called rosuvastatin can help prevent dangerous blood clots (venous thromboembolism or VTE) in people with cancer. Many cancer patients are at high risk for these clots, but cannot take standard blood thinners due to bleeding risks. You might be able to join if you are over 18, have a new or returning cancer, are starting new cancer treatment, and are not already taking statins or blood thinners. The study will compare rosuvastatin to a placebo (a pill with no medicine) over 12 months to see if it reduces the number of blood clots. The study aims to enroll 4000 participants, but its current status is unclear.

Study design: This is a randomized, double-blind study, meaning participants are randomly assigned to receive either rosuvastatin or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to include 4000 participants.
What's involved: If you join, you will take 20mg of rosuvastatin or a placebo pill by mouth daily for up to 12 months.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome of the study will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Statins to Prevent Cancer Associated Blood Clots

Recruiting

PHASE4Ages 18+InterventionalPrevention

Brigham and Women's Hospital

~4,000 participants

Updated 2026-06-12 on ClinicalTrials.gov

What's tested:RosuvastatinPlacebo Drug

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer

Measured over 12 months

Conditions

Venous Thromboembolism

Cancer

Cardiovascular Events

Where it's being run

2 sites across 1 states

Massachusetts2

Who to contact

Elaine Zaharris

[email protected]

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

age \> 18 years with no contraindication to statin therapy and able to provide informed consent

newly diagnosed, newly recurrent or newly progressive malignancy with locally advanced/metastatic disease initiating new systemic cancer therapy with no plan for prophylactic anticoagulation.

intermediate or high risk for cancer associated VTE based on the Khorana Score (KS) and modified Khorana Score (mKS) risk assessment tools (KS 2-4 or mKS 2-5).

ECOG performance status 0-2

Life expectancy \> 6 months

Exclusion

current use of statin therapy or known statin intolerance.

current use of systemic anticoagulation.

very low VTE risk defined by a Khorana Score (KS) of 0-1 and a modified Khorana Score (mKS) of 0-1.

extremely high VTE risk defined by a Khorana Score (KS) \> 5 or modified Khorana Score (mKS) \> 6 where guideline recommendations for systemic anticoagulation should be considered.

Basal cell or squamous cell carcinoma in situ cancers of the skin as the sole qualifying cancer type

ineligible cancer types where level of acuity is likely to preclude trial participation (including acute leukemia, myelodysplastic syndromes, primary brain tumors, primary CNS lymphoma, or plans to undergo hematopoietic stem cell transplantation or CAR-T cell therapy). (g) Known ALT, AST, or creatine kinase (CK) levels \> 3 x ULN; eGFR \< 30 ml/min/1.73m2, or Child Pugh Class B or C liver disease

Known hepatitis C or HIV disease, or intent to use certain oncologic agents (daralutemide, regorafenib, and cabozantinib) or some antivirals used to treat hepatitis C or HIV disease (combinations of sofosbuvir, velpatasvir, and voxilaprevir) which can significantly increase rosuvastatin exposure and potentially lead to drug-drug interactions (DDIs).

Conditions that, in the opinion of the investigator, would compromise the well-being of the subject or conduct of the study, including as examples life expectancy less than 6 months or an ECOG Performance Status \> 3.

What this trial measures

Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer12 months
The primary endpoint of the trial is the time from taking the first dose of study medication after randomization (modified intention to treat, mITT) to the first confirmed occurrence of the primary VTE endpoint. The primary analysis will use a likelihood ratio test based on a proportional hazards model stratified by eligibility criteria (eligible due to KS criteria alone or eligible due to mKS criteria), and enrollng center to test the null hypothesis of no association between assignment to active statin treatment and the rate of the primary endpoint. All analyses will classify patients according to their randomized treatment assignment, i.e. according to the intention to treat principle, and will base evaluation of statistical significance on a two-sided test with level 0.05. The estimated relative hazard in the statin compared to the placebo group with accompanying 95% confidence interval will quantify the treatment effect45. If this relative hazard is less than 1, then 100\*(1-esti

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