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RecruitingPhase 4

Statins to Prevent Cancer Associated Blood Clots

STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous Thromboembolism

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether rosuvastatin, a statin drug, can safely prevent blood clots in veins in people with cancer. It compares 20 mg daily for 12 months with a placebo, a pill with no active drug. It is for people with new or recently returned cancer who have a higher risk of blood clots and are not taking statins or planning to take blood thinners.

Patients with cancer are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage. The primary aim of the Statin Therapy to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who do not otherwise take statin therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Older than 18, able to give informed consent, and able to safely take a statin.
  • Cancer is newly diagnosed, has returned, or has gotten worse, and has spread nearby or to other parts of the body.
  • Starting a new cancer treatment that works throughout the body, with no plan to use blood thinners to prevent clots.
  • Medium or high blood clot risk: a Khorana score of 2–4 or modified Khorana score of 2–5. These scores estimate clot risk.
  • ECOG activity score of 0–2: able to care for yourself and be up and about at least half the day.
  • Expected to live more than 6 months.

Who can't join

  • Currently taking a statin, or known to be unable to tolerate statins.
  • Currently taking blood thinners.
  • Very low clot risk: both Khorana scores are 0–1. Or extremely high risk: Khorana score above 5 or modified score above 6.
  • The only qualifying cancer is basal cell skin cancer or squamous cell skin cancer in situ, which has not spread beyond where it started.
  • Acute leukemia; myelodysplastic syndromes, which affect blood cell production; tumors that start in the brain; or lymphoma that starts in the brain or spinal cord. Planned blood-forming stem cell transplant or CAR-T treatment, which uses changed immune cells, also rules out joining.
  • Liver or muscle blood tests (ALT, AST, or CK) above 3 times the upper normal limit; kidney filtering rate (eGFR) below 30; or moderate to severe liver disease (Child-Pugh class B or C).
  • Known hepatitis C or HIV, or plans to take daralutemide, regorafenib, cabozantinib, or antiviral combinations of sofosbuvir, velpatasvir, and voxilaprevir. These drugs may raise rosuvastatin levels.
  • Any condition the study doctor thinks could harm your well-being or affect the study, such as an expected lifespan under 6 months or an ECOG activity score above 3.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (9)

CA

CT

FL

MA

MN

OH

TX