NCT04319627 Statins for Venous Event Reduction in Patients With Venous Thromboembolism
| NCT ID | NCT04319627 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,700 participants |
| Start Date | 2021-02-10 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,700 participants in total. It began in 2021-02-10 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 blood thinners is effective, some research has shown that adding a statin (medication used to lower cholesterol) may give extra protection. It is thought that statins can improve how cells along the walls of the vein control inflammation, which can prevent new blood clots from forming. The medication in this study, rosuvastatin, is approved in Canada for use as a cholesterol-lowering medication. The use of rosuvastatin in this study is considered investigational. This means that Health Canada has not approved the use of rosuvastatin as a treatment for blood clots. However, it has been approved for use in this research study. The purpose of this study is to examine if adding a statin (rosuvastatin) to the usual blood thinner treatment will decrease the risk of another blood clot forming. The investigators also hope to discover if taking a statin reduces damage to your veins. To do this, some of the participants in this study will get rosuvastatin and others will receive a placebo (a substance that looks like the study rosuvastatin but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on your blood clot. A placebo is used to make the results of the study more reliable.
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.
Contact & Investigator
Aurélien Delluc, MD
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT04319627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04319627 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,700 participants.
Is NCT04319627 currently recruiting?
Yes, NCT04319627 is actively recruiting participants. Contact the research team at jbrinkhurst@ohri.ca for enrollment information.
Where is the NCT04319627 trial being conducted?
This trial is being conducted at Calgary, Canada, Halifax, Canada, Hamilton, Canada, Hamilton, Canada and 11 additional locations.
Who is sponsoring the NCT04319627 clinical trial?
NCT04319627 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Aurélien Delluc, MD at Ottawa Hospital Research Institute. The trial plans to enroll 2,700 participants.