Study of Adding Rosuvastatin to Usual Blood Thinner Treatment to Reduce Blood Clots in Adults with Venous Thromboembolism

What this Trial Is About

Researchers are evaluating whether adding a statin medication called rosuvastatin to the usual blood thinner treatment can reduce the risk of new blood clots in patients diagnosed with deep vein thrombosis or pulmonary embolism. This study focuses on patients with symptomatic major venous thromboembolism and aims to see if rosuvastatin decreases recurrent clotting and vein damage compared to a placebo. The study is a Phase 3 randomized controlled trial designed to explore potential benefits beyond standard anticoagulant therapy. Participants will be randomly assigned to one of two groups one group will take a daily 20 mg tablet of rosuvastatin, while the other will receive a daily placebo tablet that looks like rosuvastatin but contains no active medication. All participants will continue to receive their usual blood thinner treatment alongside the study medication or placebo. The study treatments will be taken by mouth for the entire duration of participation, which can last up to 60 months. During the study, participants will undergo regular assessments to monitor for new or recurrent venous thromboembolism events, bleeding events, and vein health using the Villalta scale. Researchers will also track arterial vascular events and overall survival during follow-up. The study involves long-term monitoring up to five years to evaluate safety and effectiveness. Participants will be monitored closely to ensure adherence and safety throughout the study period.

Statins for Venous Event Reduction in Patients With Venous Thromboembolism