Statins for Venous Event Reduction in Patients With Venous Thromboembolism (SAVER)

  • STATUS
    Recruiting
  • End date
    Jan 22, 2027
  • participants needed
    2700
  • sponsor
    Ottawa Hospital Research Institute
Updated on 22 March 2022
thrombosis
clot
anticoagulants
rosuvastatin
statin
venous thromboembolism
deep vein thrombosis
thromboembolism
blood clot
embolism

Summary

The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants).

While treatment of blood clots with blood thinners is effective, some research has shown that adding a statin (medication used to lower cholesterol) may give extra protection. It is thought that statins can improve how cells along the walls of the vein control inflammation, which can prevent new blood clots from forming.

The medication in this study, rosuvastatin, is approved in Canada for use as a cholesterol-lowering medication. The use of rosuvastatin in this study is considered investigational. This means that Health Canada has not approved the use of rosuvastatin as a treatment for blood clots. However, it has been approved for use in this research study.

The purpose of this study is to examine if adding a statin (rosuvastatin) to the usual blood thinner treatment will decrease the risk of another blood clot forming. The investigators also hope to discover if taking a statin reduces damage to your veins. To do this, some of the participants in this study will get rosuvastatin and others will receive a placebo (a substance that looks like the study rosuvastatin but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on your blood clot. A placebo is used to make the results of the study more reliable.

Details
Condition Venous Thromboembolism, Blood Clot, Post Thrombotic Syndrome
Treatment Placebo Oral Tablet, Rosuvastatin Calcium
Clinical Study IdentifierNCT04319627
SponsorOttawa Hospital Research Institute
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days

Exclusion Criteria

Unable or unwilling to provide written informed consent
≤ 18 years of age
Currently prescribed a statin
Women of childbearing potential unwilling to use appropriate contraception
Diabetes
A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention
Abdominal aortic aneurysm
Stroke
Peripheral arterial disease
Transient ischemic attack (TIA)
Myocardial infarction (MI)
Acute coronary syndromes
Stable/unstable angina
Coronary or other arterial revascularization
Known diagnosis of hypercholesterolemia or dyslipidemia
Contraindication to rosuvastatin
Known hypersensitivity or intolerance to statins
History of muscle disorders or statin-related muscle pain
Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver)
Chronic kidney disease (creatinine clearance < 30ml/min)
Taking cyclosporine
Currently pregnant or breast feeding
Taking atazanavir/ritonavir
Taking darolutamide
Taking regorafenib
Unstable medical or psychological condition that would interfere with trial
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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