Status:
RECRUITING
Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Lead Sponsor:
Aurelien Delluc
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Eastern Norway Health Authorities RHF
Conditions:
Venous Thromboembolism
Blood Clot
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants). While treatment of blood clots with bl...
Detailed Description
Recent research has demonstrated that it is plausible that statins have additive, and potentially even synergistic effects, in reducing recurrent VTE in patients managed with anticoagulant-based strat...
Eligibility Criteria
Inclusion
- 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
- Unable or unwilling to provide written informed consent;
- \< 18 years of age;
- Women of childbearing potential unwilling to use appropriate contraception;
- Currently prescribed a statin;
- A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:
- Diabetes;
- Abdominal aortic aneurysm;
- Peripheral arterial disease;
- Stroke;
- Transient ischemic attack (TIA);
- Myocardial infarction (MI);
- Acute coronary syndromes;
- Stable/unstable angina;
- Coronary or other arterial revascularization;
- Known diagnosis of hypercholesterolemia or dyslipidemia;
- Contraindication to rosuvastatin;
- Known hypersensitivity or intolerance to statins;
- History of muscle disorders or statin-related muscle pain;
- Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
- Chronic kidney disease (creatinine clearance \< 30ml/min);
- Currently pregnant or breast feeding;
- Taking cyclosporine;
- Taking atazanavir/ritonavir;
- Taking darolutamide;
- Taking regorafenib;
- Unstable medical or psychological condition that would interfere with trial participation.
Exclusion
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT04319627
Start Date
February 10 2021
End Date
April 1 2028
Last Update
December 17 2025
Active Locations (31)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9
3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
4
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6