Recruiting

Phase 4

RosuvastatinStatins to Prevent Cancer Associated Blood Clots

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

Sep, 2026

Completion date

Mar 31, 2032

Anticipated

Primary completion date

Mar 31, 2031

Anticipated

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

857-282-0022 ezaharris@bwh.harvard.edu

Locations

City of Hope

Recruiting

Irvine, California, United States, 90101

Contacts

Faizi Jamal, MD

626-218-2491 fjamal@coh.org

Monique French

626-218-4288 mfrench@coh.org

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Yevgeniya Foster, MD

203-200-4363 gena.foster@yale.edu

Jailing Zhang

475-234-9684 jialing.zhang@yale.edu

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Gerald Soff, MD

305-243-7359 gas199@miami.edu

Mir Anwar

305-243-6995 manwar@med.miami.edu

Beth Isreal Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Rushad Patell, MD

617-677-9920 rpatell@bidmc.harvard.edu

Fernanda Dequier

617-975-7454 fdequeir@bidmc.harvard.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jean Connors, MD

857-215-4616 jean_connors@dfci.harvard.edu

Julianna Dick

857-215-4616 juliana_dick@dfci.harvard.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kathryn Ruddy, MD

507-284-2511 Ruddy.Kathryn@mayo.edu

Sandy Looney

507-422-5043 looney.sandy@mayo.edu

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Cristhiam Rojas Hernandez, MD

346-228-0622 CMRojas@mdanderson.org

Ashley Rodriguez

346-228-0622 ajrodriguez1@mdanderson.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

statin
pulmonary embolism
rosuvastatin
cancer
venous thromboembolism
prophylactic anticoagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.