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Taking peoplePhase 3

Rosuvastatin added to blood thinners for people with blood clots in veins or lungs

Tests rosuvastatin versus placebo alongside blood thinners in adults with venous blood clots.

Key facts

Who runs it
Ottawa Hospital Research Institute
Where
Canada, France, Ireland, Italy, Norway, and United Kingdom36 sites in 6 countriesChoose a country to see its sites
Registry title
Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Status
Recruiting
Phase
Phase 3
People taking part
2,700 people, planned
Started
10 Feb 2021
Expected to end
Apr 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Rosuvastatin Calcium
  • Placebo Oral Tablet
Record updated
15 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a recent blood clot in the leg (DVT) and/or lung (PE). It tests whether adding rosuvastatin to usual blood thinners lowers the chance of another clot.

Age
18 years and older
Sex
All sexes
Disease stage
A clot with symptoms, confirmed by tests, in a deep vein of the upper leg (above the trifurcation of the popliteal vein) and/or a segmental or larger PE. It must have been diagnosed in the last 30 days.
Earlier treatment
People currently prescribed a statin cannot join.

Main reasons for not taking part

  • Diabetes, stroke, TIA, heart attack, angina, or other artery disease for which statins are used
  • Known high cholesterol or dyslipidemia
  • Allergy or intolerance to statins, muscle disorders, liver disease, or chronic kidney disease (creatinine clearance < 30ml/min)
  • Pregnant or breastfeeding, or unwilling to use birth control if able to become pregnant
  • Taking cyclosporine, atazanavir/ritonavir, darolutamide or regorafenib

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Unstable medical or psychological condition that would interfere with trial participation
  • 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
  • < 18 years of age
  • Unable or unwilling to provide written informed consent
  • Women of childbearing potential unwilling to use appropriate contraception
  • Currently prescribed a statin
  • Known diagnosis of hypercholesterolemia or dyslipidemia

This trial has no sites in United States.

It has sites in 6 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • RosuvastatinTreatment being tested

    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.

    Treatment: Rosuvastatin Calcium

  • PlaceboPlacebo, for comparison

    Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.

    Treatment: Placebo Oral Tablet

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Plain-language title
Rosuvastatin added to blood thinners for people with blood clots in veins or lungsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
15 January 2026