Rosuvastatin for Cancer-Associated Blood Clots
(STAT-CAT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether rosuvastatin, a cholesterol-lowering medication, can safely prevent blood clots in people with cancer. These blood clots, known as venous thromboembolism (VTE), pose a common and serious risk for those with newly diagnosed or recently relapsed cancer. Participants will take either rosuvastatin or a placebo for 12 months to determine if the medication reduces clot risk without causing bleeding. Suitable candidates for this trial include individuals beginning new cancer treatments who are not currently using blood thinners and have a moderate to high risk of blood clots. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using statin therapy or systemic anticoagulation. If you are taking certain cancer or antiviral medications, you may also be excluded due to potential interactions with the trial drug.
What is the safety track record for this treatment?
Research has shown that rosuvastatin is generally safe for use. In studies with cancer patients, those taking statins like rosuvastatin had a lower risk of developing blood clots compared to those not taking statins. Specifically, one study found that only 8% of cancer patients on statins developed blood clots, while 21% of those not on statins did.
The FDA has already approved rosuvastatin for managing cholesterol, indicating its safety is well understood. Most people experience only mild side effects, such as headaches or muscle pain, and serious side effects are rare. This information supports the safety of using rosuvastatin to prevent blood clots in cancer patients, but monitoring for any side effects during the trial remains important.12345Why are researchers enthusiastic about this study treatment?
Most treatments for cancer-associated blood clots typically involve anticoagulants like warfarin or direct oral anticoagulants (DOACs), which work by thinning the blood to prevent clotting. However, rosuvastatin is unique because it is a statin, primarily used to lower cholesterol, but it also has anti-inflammatory properties that could reduce the formation of clots. This dual action not only targets cholesterol levels but may also directly influence the mechanisms of clot formation associated with cancer. Researchers are excited about rosuvastatin because it could offer a new approach to managing blood clots in cancer patients, potentially with fewer bleeding risks compared to traditional blood thinners.
What evidence suggests that rosuvastatin might be an effective treatment for cancer-associated blood clots?
Research shows that rosuvastatin, which participants in this trial may receive, might help lower the risk of blood clots in people with cancer. Studies have found that statins, like rosuvastatin, reduce the risk of venous thromboembolism (VTE), a type of blood clot. Specifically, research has shown that rosuvastatin can lower certain risk factors for these clots. One study highlighted that statins have a strong protective effect against blood clots, especially in some types of cancer. Overall, evidence suggests that rosuvastatin could be a promising option for preventing blood clots in cancer patients.13456
Are You a Good Fit for This Trial?
This trial is for adult cancer patients with a high risk of blood clots, as determined by specific scoring tools. They should be starting new cancer treatments without planned blood thinner use, have a life expectancy over 6 months, and be able to perform daily activities with minimal assistance.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 20 mg of rosuvastatin or placebo daily for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rosuvastatin
Trial Overview
The STAT-CAT trial is testing if taking Rosuvastatin (a cholesterol-lowering drug) every day for a year can prevent dangerous blood clots in patients with newly diagnosed or recently worsened cancer who are at increased risk of these clots.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Dana-Farber/Brigham and Women's Cancer Center
Collaborator
Citations
Statins to Prevent Cancer Associated Blood Clots
Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer ...
2.
ashpublications.org
ashpublications.org/bloodadvances/article/9/17/4472/537626/The-efficacy-of-rosuvastatin-to-reduce-circulatingThe efficacy of rosuvastatin to reduce circulating tissue factor ...
We hypothesized that rosuvastatin could reduce circulating EV after ovarian cancer surgery.
Effect of rosuvastatin on risk markers for venous ...
Statin therapy is associated with lower risk of venous thromboembolism (VTE) but has not been prospectively evaluated in patients with advanced cancer.
Statin use and venous thromboembolism in cancer
The overall model showed a statistically significant protective effect for statins compared to no treatment attributed only to leukemia for DVT (HR = 0.77, 95% ...
Effect of rosuvastatin on risk markers for venous ...
Statins lower venous thromboembolism risk in general but have not been studied in cancer patients. We completed a randomized trial of ...
Effect of rosuvastatin on risk markers for venous ...
Statin therapy is associated with lower risk of venous thromboembolism (VTE) but has not been prospectively evaluated in patients with advanced cancer.
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