Statins for Venous Event Reduction in Patients With Venous Thromboembolism (SAVER)
Venous Thromboembolism, Blood Clot, Post Thrombotic Syndrome
About this trial
This is an interventional treatment trial for Venous Thromboembolism focused on measuring Rosuvastatin, Statin, PTS, VTE
Eligibility Criteria
Inclusion Criteria:
1. 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;
- Women of childbearing potential unwilling to use appropriate contraception;
- Currently prescribed a statin;
A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:
- Diabetes;
- Abdominal aortic aneurysm;
- Peripheral arterial disease;
- 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, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
- Chronic kidney disease (creatinine clearance < 30ml/min);
- Currently pregnant or breast feeding;
- Taking cyclosporine;
- Taking atazanavir/ritonavir;
- Taking darolutamide;
- Taking regorafenib;
- Unstable medical or psychological condition that would interfere with trial participation.
Sites / Locations
- Foothills Medical CentreRecruiting
- Queen Elizabeth II HospitalRecruiting
- Hamilton General HospitalRecruiting
- St. Joseph's Healthcare
- Juravinski HospitalRecruiting
- The Ottawa HospitalRecruiting
- Hôpital MontfortRecruiting
- Niagara Health - St. Catharines SiteRecruiting
- Sunnybrook Hospital
- University Health Network
- Jewish General HospitalRecruiting
- McGill Univeristy Health CentreRecruiting
- CHU de Quebec-Université LavalRecruiting
- Brest University Hospital Centre
- Mater Misericordiae University Hospital
- University of Insubria
- Amsterdam University
- Ostfold Hopsital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rosuvastatin
Placebo
Participants randomized to the experimental arm will take one rosuvastatin 20 mg tablet by mouth every day for the duration of their participation in the study.
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.