drugset / Trial / NCT02331095
Statin Use in Patients With Acute VTE
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |
| Background | Rivaroxaban | Other / unclassified | 20 mg | — |
| Background | Warfarin | Small molecule | — | — |