Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Mar 23, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called rosuvastatin, which is usually used to lower cholesterol, can help patients who have experienced a blood clot (like deep vein thrombosis or pulmonary embolism). The researchers want to find out if taking rosuvastatin along with standard blood thinner treatment can reduce the chances of getting another blood clot and help protect the veins from damage.

To be eligible for this trial, participants need to be between the ages of 65 and 74 and have been diagnosed with a significant blood clot in the last 30 days. Some participants will receive rosuvastatin, while others will receive a placebo, which looks like the real medication but has no active ingredients. This helps the researchers compare results more reliably. If you decide to take part, you will be monitored throughout the study to see how well the treatment works. It's important to know that while rosuvastatin is approved for cholesterol management, its use for blood clots is still being researched.

Gender

ALL

Eligibility 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. Women of childbearing potential unwilling to use appropriate contraception;
• • 4. Currently prescribed a statin;
• 5. A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:
• • 1. Diabetes;
• • 2. Abdominal aortic aneurysm;
• • 3. Peripheral arterial disease;
• • 4. Stroke;
• • 5. Transient ischemic attack (TIA);
• • 6. Myocardial infarction (MI);
• • 7. Acute coronary syndromes;
• • 8. Stable/unstable angina;
• • 9. Coronary or other arterial revascularization;
• • 6. Known diagnosis of hypercholesterolemia or dyslipidemia;
• • 7. Contraindication to rosuvastatin;
• • 1. Known hypersensitivity or intolerance to statins;
• • 2. History of muscle disorders or statin-related muscle pain;
• • 3. Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
• • 4. Chronic kidney disease (creatinine clearance \< 30ml/min);
• • 5. Currently pregnant or breast feeding;
• • 6. Taking cyclosporine;
• • 7. Taking atazanavir/ritonavir;
• • 8. Taking darolutamide;
• • 9. Taking regorafenib;
• • 8. Unstable medical or psychological condition that would interfere with trial participation.