Statins for Venous Event Reduction in Patients With Venous Thromboembolism

  • STATUS
    Recruiting
  • End date
    Jan 5, 2027
  • participants needed
    2700
  • sponsor
    Ottawa Hospital Research Institute
Updated on 5 March 2021
Investigator
Lesley Yeung, BSc
Primary Contact
Mater Misericordiae University Hospital (2.8 mi away) Contact
+11 other location

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 stasis, Venous Thromboembolism, Thromboembolism, Thrombosis, Blood Clots, clot, blood clot, post thrombotic syndrome, blood clotting
Treatment Placebo Oral Tablet, Rosuvastatin Calcium
Clinical Study IdentifierNCT04319627
SponsorOttawa Hospital Research Institute
Last Modified on5 March 2021

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
A known medical history or current diagnosis of any of the following
Diabetes
Abdominal aortic aneurysm
Peripheral arterial disease presumed to be of atherosclerotic origin
Stroke
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 or unexplained elevations of serum transaminases exceeding 3 times the upper limit of normal)
Chronic kidney disease (Creatinine clearance < 30ml/min within previous 3 months)
Currently pregnant or breast-feeding
Taking cyclosporine
Unstable medical or psychological condition that would interfere with trial participation
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