drugset / Trial / NCT02679664

StAtins for Venous Event Reduction in Patients With Venous Thromboembolism Pilot Study

NCT02679664

Phase 2 Unknown 312 enrolled Ottawa Hospital Research Institute
RandomizedParallel-groupOpen-labelPrevention

Summary

The SAVER pilot is a randomized, open-label pilot study to determine the feasibility of recruitment. In addition to feasibility data, the investigators will carefully collect clinical data to determine if rosuvastatin can reduce post-thrombotic syndrome (PTS) in venous thromboembolism (VTE) patients. Eligible consenting patients who developed acute, symptomatic, and objectively confirmed proximal leg deep vein thrombosis (DVT) and/or PE will be randomized and equally allocated to 2 trial arms, either the treatment group (rosuvastatin tablet (20 mg/day) or the control group (usual care). The pilot trial consists of up to 4 study contacts over 6 months: screening, randomization, telephone follow-up (90 days), and final study visit (180 days).

Timeline

Start
2016-11
Primary completion
2020-01-13
Completion
2020-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosuvastatin Small molecule 20 mg Oral