Using rosuvastatin to reduce blood clots in patients with venous thromboembolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of rosuvastatin, a cholesterol-lowering medication, in reducing the risk of recurrent venous thromboembolism (VTE) in patients who have recently experienced a major VTE event. Participants will be randomly assigned to receive either rosuvastatin or a placebo in addition to standard anticoagulant therapy. The study aims to determine if the addition of rosuvastatin can lower the incidence of symptomatic recurrent major VTE and assess its impact on post-thrombotic syndrome. The trial will also monitor for any major bleeding events associated with the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Foothills Medical Centre
  Calgary, Alberta, Canada Recruiting
• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting
• St. Joseph's Healthcare
  Hamilton, Ontario, Canada Recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• Niagara Health - St. Catharines Site
  St. Catharines, Ontario, Canada Recruiting
• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Aurélien Delluc, MD — Ottawa Hospital Research Institute
• Study coordinator: Jennifer Brinkhurst
• Email: jbrinkhurst@ohri.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.