Statins to Prevent Cancer Associated Blood Clots

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

Sep 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

• Elaine Zaharris
  857-282-0022
  [email protected]

Locations (9)

Find similar trials in Irvine, CA

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