Recruiting

Rosuvastatin

Sponsor:

Brigham and Women's Hospital

Code:

NCT07303816

Conditions

Venous Thromboembolism

Cancer

Cardiovascular Events

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rosuvastatin

Placebo Drug

Study Details

Brief summary:

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.

Conditions

Venous Thromboembolism

Cancer

Cardiovascular Events

Study ID

NCT07303816

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Mar 31, 2032

Anticipated

Primary completion date

Mar 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Active Rosuvastatin Arm

Patients in the Active Rosuvastatin Arm will take 20mg rosuvastatin daily for a period of 12 months. Note: This is a double-blinded study so patients and providers will not know what arm they are in.

placebo comparator: Placebo Arm

Patients in the Placebo Arm will take 20mg placebo daily for a period of 12 months. Note: This is a double-blinded study so patients and providers will not know what arm they are in.

Interventions

Rosuvastatin

Rosuvastatin is a statin drug that helps reduce cholesterol and can help reduce risks of blood clots. In this study, patients will take 20mg of Rosuvastatin (or placebo) for to 12 months.

Placebo Drug

The placebo pills are pills with no medicine in them.

Primary outcome measure

  • Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Elaine Zaharris

ezaharris@bwh.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jean Connors, MD

jean_connors@dfci.harvard.edu

Christine Cronin, MHA

617-632-3784christine_cronin@dfci.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • statin
  • pulmonary embolism
  • rosuvastatin
  • cancer
  • venous thromboembolism
  • prophylactic anticoagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-12.