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Using rosuvastatin to reduce blood clots in patients with venous thromboembolism

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

PHASE3 · Ottawa Hospital Research Institute · NCT04319627

This study is testing if adding rosuvastatin, a cholesterol-lowering drug, can help prevent blood clots from coming back in patients who have recently had a major blood clot event.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment2700 (estimated)
Ages18 Years and up
SexAll
SponsorOttawa Hospital Research Institute (other)
Locations31 sites (Calgary, Alberta and 30 other locations)
Trial IDNCT04319627 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults who have been diagnosed with symptomatic proximal leg deep vein thrombosis or pulmonary embolism within the last 30 days.

Not a fit: Patients currently prescribed a statin or those with contraindications to rosuvastatin will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option to reduce the risk of recurrent blood clots for patients with venous thromboembolism.

How similar studies have performed: While the use of statins in this context is novel, previous studies have suggested potential benefits, but no randomized controlled trials have been conducted to confirm these findings.

Eligibility criteria

Show full inclusion / exclusion 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

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 this trial is running

Calgary, Alberta and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Venous Thromboembolism, Blood Clot, Post Thrombotic Syndrome, Rosuvastatin, Statin, PTS, VTE

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.