drugset / Trial / NCT02331095

Statin Use in Patients With Acute VTE

NCT02331095

Phase 0 Terminated 21 enrolled Ohio State University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and randomized 1:1 into "anticoagulation" arm or "anticoagulation plus atorvastatin" arm, with atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80 patients, with 40 in each arm. Patients will be recruited from the hospitals and clinics at The Ohio State University Wexner Medical Center. Follow up visits are planned at enrollment, 3 months, and 9 months after randomization. At each follow up, blood will be obtained and assessments will include structured interviews of signs and symptoms of recurrent venous thromboembolism (VTE), bleeding, post thrombotic syndrome, and adverse events from study drugs.

Timeline

Start
2015-01
Primary completion
2017-10-27
Completion
2020-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg Oral
Background Rivaroxaban Other / unclassified 20 mg
Background Warfarin Small molecule