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New treatment option for Venous Thromboembolism
Official title Statins for Venous Event Reduction in Patients With Venous Thromboembolism
ClinicalTrials.gov ID: NCT04319627
What this study is testing
What is Rosuvastatin Calcium?
Rosuvastatin Calcium is an investigational medicine, being studied as a potential treatment for venous thromboembolism.
Also referred to as Rosuvastatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in...
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Angers, France
- Brest, France
- Clermont-Ferrand, France
- Colombes, France
- Dijon, France
- La Rochelle, France
- Saint-Etienne, France
- Toulon, France
- Dublin, Ireland
- Varese, Italy
- Sarpsborg, Norway
- Aberdeen, United Kingdom
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; St. Catharines, Ontario, Canada; Toronto, Ontario, Canada and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.