Statin Use in Patients With Acute VTE

• Status: Terminated
• Trial end date: 2020-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Atorvastatin; Atorvastatin Calcium; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

• At least 18 years old

• A diagnosis of proximal DVT (proximal to and including popliteal vein), with or without PE, confirmed by objective imaging studies, such as Doppler ultrasound, venograms (for DVT) and/or computer tomography, angiograms, ventilation-perfusion scan (for PE)

• Treated with warfarin as anticoagulation (short-term bridging with heparin or lovenox is allowed)

Exclusion Criteria:

• Thrombolysis within 6 weeks prior to enrollment

• Patients with statin use within 6 weeks of enrollment

• Patients with known allergy or intolerance to statins or statins are contraindicated for any other reasons

• Patients with baseline aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 x upper limit of normal (ULN)

• Pregnant or breastfeeding females are excluded

• Any malignancy diagnosed within the preceding 2 years, except for squamous cell carcinoma or basal cell carcinoma of skin treated with local resection only, or carcinoma in situ of the cervix

• Incarcerated patients are excluded from the study due to the inherent difficulties in maintaining close follow-up for study purposes in patients who are incarcerated.