Statins to Prevent Cancer Associated Blood Clots

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07303816
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cancer
  • Cardiovascular Events
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rosuvastatin — DRUG
    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 — DRUG
    The placebo pills are pills with no medicine in them.

Study Details

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.

Key Dates

First listed
Dec 26, 2025
Start date
Jun 11, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2032

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jean Connors, MD
[email protected]
Christine Cronin, MHA
[email protected]
617-632-3784

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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