Statins for Venous Event Reduction in Patients With Venous Thromboembolism

• Status: Recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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 (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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

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. Currently prescribed a statin;

4. A known medical history or current diagnosis of any of the following:

• Diabetes,

• Abdominal aortic aneurysm,

• Peripheral arterial disease presumed to be of atherosclerotic origin,

• Stroke,

• Transient ischemic attack (TIA),

• Myocardial infarction (MI),

• Acute coronary syndromes,

• Stable/unstable angina,

• Coronary or other arterial revascularization;

5. Known diagnosis of hypercholesterolemia or dyslipidemia;

6. Contraindication to rosuvastatin:

• Known hypersensitivity or intolerance to statins,

• History of muscle disorders or statin-related muscle pain,

• Known liver disease (active liver disease or unexplained elevations of serum transaminases exceeding 3 times the upper limit of normal),

• Chronic kidney disease (Creatinine clearance < 30ml/min within previous 3 months),

• Currently pregnant or breast-feeding,

• Taking cyclosporine;

7. Unstable medical or psychological condition that would interfere with trial participation.