Venous ThromboembolismPhase 4STAT-CATNCT07303816
Statins to Prevent Cancer Associated Blood Clots
A Phase 4 study testing Rosuvastatin in people with Venous Thromboembolism and Cancer, run by Brigham and Women's Hospital at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer, Cardiovascular Events
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Jun 2026to 31 Mar 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
Rushad Patell, MD, 617-677-9920, rpatell@bidmc.harvard.edu
Fernanda Dequier, 617-975-7454, fdequeir@bidmc.harvard.edu
- Active, not recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Jean Connors, MD, 857-215-4616, jean_connors@dfci.harvard.edu
Julianna Dick, 857-215-4616, juliana_dick@dfci.harvard.edu
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Alok Khorana, MD, 216-636-2690, khorana@ccf.org
Brian Zeise, 216-442-4972, zeiseb@ccf.org
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cristhiam Rojas Hernandez, MD, 346-228-0622, CMRojas@mdanderson.org
Ashley Rodriguez, 346-228-0622, ajrodriguez1@mdanderson.org
- Recruiting
City of Hope
Irvine, California, 90101
Faizi Jamal, MD, 626-218-2491, fjamal@coh.org
Monique French, 626-218-4288, mfrench@coh.org
- Recruiting
University of Miami
Miami, Florida, 33136
Gerald Soff, MD, 305-243-7359, gas199@miami.edu
Mir Anwar, 305-243-6995, manwar@med.miami.edu
- Recruiting
Yale University
New Haven, Connecticut, 06511
Yevgeniya Foster, MD, 203-200-4363, gena.foster@yale.edu
Jailing Zhang, 475-234-9684, jialing.zhang@yale.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Kathryn Ruddy, MD, 507-284-2511, Ruddy.Kathryn@mayo.edu
Sandy Looney, 507-422-5043, looney.sandy@mayo.edu
About this study
Official title: STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous Thromboembolism
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.
Read the detailed description
This trial is a randomized, double-blind, placebo-controlled trial of rosuvastatin 20 mg po daily in the prevention of venous thromboembolism (VTE) and other cardiovascular events among individuals recently diagnosed with cancer who are not scheduled to receive prophylactic anticoagulation and are at risk for VTE as defined by a Khorana Score (KS) 2 to 4 or a modified Khorana Score (mKS) 2 to 5.
- Conditions
- Venous Thromboembolism, Cancer, Cardiovascular Events
- Being tested
- Rosuvastatin, Placebo Drug
- Keywords
- statin, pulmonary embolism, rosuvastatin, cancer, venous thromboembolism, prophylactic anticoagulation
- Medical subject headings
- Venous Thromboembolism, Neoplasms, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
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 DrugDrug
The placebo pills are pills with no medicine in them.
| Study group | Role | What they receive |
|---|---|---|
| Active Rosuvastatin Arm | Experimental | 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. Receives: Drug: Rosuvastatin |
| Placebo Arm | Placebo comparator | 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. Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer
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
Measured: 12 months
Secondary outcomes (1)
Assess whether Rosuvastatin versus placebo over a period of one year reduces the cumulative incidence of a composite of venous and arterial thrombosis events among patients with cancer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start11 Jun 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled trial of rosuvastatin 20 mg po daily in the prevention of venous thromboembolism (VTE) and other cardiovascular events among individuals recently diagnosed with cancer
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Dana-Farber/Brigham and Women's Cancer Center
- Responsible party
- Principal investigator, Paul Ridker, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303816
- Sponsor's protocol ID
- 25-789
- Other IDs
- UG3HL176627
- Acronym
- STAT-CAT
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT07303816
- Acronym / sponsor ID
- STAT-CAT / 25-789
- Conditions
- Venous Thromboembolism, Cancer, Cardiovascular Events
- Keywords
- statin, pulmonary embolism, rosuvastatin, cancer, venous thromboembolism, prophylactic anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Dana-Farber/Brigham and Women's Cancer Center
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is a randomized, double-blind, placebo-controlled trial of rosuvastatin 20 mg po daily in the prevention of venous thromboembolism (VTE) and other cardiovascular events among individuals recently diagnosed with cancer who are not scheduled to receive prophylactic anticoagulation and are at risk for VTE as defined by a Khorana Score (KS) 2 to 4 or a modified Khorana Score (mKS) 2 to 5.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled trial of rosuvastatin 20 mg po daily in the prevention of venous thromboembolism (VTE) and other cardiovascular events among individuals recently diagnosed with cancer
| Arm | Type | Receives |
|---|---|---|
| Active Rosuvastatin Arm | Experimental | Drug: RosuvastatinPatients 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 Arm | Placebo comparator | Drug: Placebo DrugPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinRosuvastatin 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. | Drug | Active Rosuvastatin Arm |
| Placebo DrugThe placebo pills are pills with no medicine in them. | Drug | Placebo Arm |
Primary outcome
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
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
1 secondary outcome
Assess whether Rosuvastatin versus placebo over a period of one year reduces the cumulative incidence of a composite of venous and arterial thrombosis events among patients with cancer
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Venous Thromboembolism and Cancer, run by Brigham and Women's Hospital at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Zaharris (857-282-0022, ezaharris@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.