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Statins for Venous Event Reduction in Patients With Venous Thromboembolism

RecruitingPhase 3Ages 18 Years - anyAllOttawa Hospital Research Institute
NCT04319627 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (rosuvas

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📋 Eligibility rules (as published)
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 1. Unable or unwilling to provide written informed consent; 2. \< 18 years of age; 3. Women of childbearing potential unwilling to use appropriate contraception; 4. Currently prescribed a statin; 5. A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention: 1. Diabetes; 2. Abdominal aortic aneurysm; 3. Peripheral arterial disease; 4. Stroke; 5. Transient ischemic attack (TIA); 6. Myocardial infarction (MI); 7. Acute coronary syndromes; 8. Stable/unstable angina; 9. Coronary or other arterial revascularization; 6. Known diagnosis of hypercholesterolemia or dyslipidemia; 7. Contraindication to rosuvastatin; 1. Known hypersensitivity or intolerance to statins; 2. History of muscle disorders or statin-related muscle pain; 3. Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver); 4. Chronic kidney disease (creatinine clearance \< 30ml/min); 5. Currently pregnant or breast feeding; 6. Taking cyclosporine; 7. Taking atazanavir/ritonavir; 8. Taking darolutamide; 9. Taking regorafenib; 8. Unstable medical or psychological condition that would interfere with trial participation.
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What it tests

  • Rosuvastatin Calcium
  • Placebo Oral Tablet
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Where

31 sites
Foothills Medical Centre
Calgary, Canada
Queen Elizabeth II Hospital
Halifax, Canada
Hamilton General Hospital
Hamilton, Canada
St. Joseph's Healthcare
Hamilton, Canada
Juravinski Hospital
Hamilton, Canada
The Ottawa Hospital
Ottawa, Canada
Hôpital Montfort
Ottawa, Canada
Niagara Health - St. Catharines Site
St. Catharines, Canada

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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