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

• Status: Active, not recruiting
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days.

Exclusion Criteria:

1. Unable or unwilling to provide written informed consent

2. ≤ 18 years of age

3. Currently prescribed a statin

4. A medical history or current diagnosis of any of the following:

• Abdominal aortic aneurysm,

• Peripheral arterial disease,

• Stroke,

• Transient ischemic attack (TIA),

• Myocardial infarction (MI),

• Acute coronary syndromes,

• Stable angina,

• Coronary or other arterial revascularization

5. LDL-C >4.91 mmol/L

6. LDL-C between 1.81mmol/L to 4.9mmol/L AND 10 ASCVD risk score >10%

7. Diabetes mellitus or pre-diabetes

8. Contraindication to rosuvastatin;

• Hypersensitivity or intolerance to statins;

• History of muscle disorders or statin-related muscle pain;

• Liver disease (active liver disease or unexplained elevations of serum transaminases exceeding 3 times the upper limit of normal);

• Chronic kidney disease (Creatinine clearance < 30ml/min)

• Currently pregnant or breast feeding;

• Taking cyclosporine.

9. Life expectancy less than 3 months, as judged by the investigator

10. Unstable medical or psychological condition that would interfere with trial participation.