Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Recent research has demonstrated that it is plausible that statins have additive, and potentially even synergistic effects, in reducing recurrent VTE in patients managed with anticoagulant-based strategies. Furthermore, it is plausible that statins may reduce the risk of recurrent VTE in those not on anticoagulants and therefore offer an alternative in patients with contraindications to anticoagulants (e.g. after major intracranial bleed), who refuse to take anticoagulants long-term (e.g. due to lifestyle modifications or fear of bleeding) or who cannot afford anticoagulants (e.g. vulnerable or impoverished populations). Finally, statins may also provide protection from recurrent VTE in patients who are not fully compliant with anticoagulant therapy. However, no known RCTs have been done to explore these possibilities.

This study aims to determine if generic rosuvastatin reduces the risk of recurrent VTE compared to placebo in patients with symptomatic major VTE.

Primary Objectives

• To determine the primary outcome event rate (i.e. symptomatic recurrent major VTE [proximal DVT or segmental or larger PE]) in patients taking generic rosuvastatin compared to placebo.

Secondary Objectives

• To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo.
• To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study.

Inclusion criteria

• 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

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