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Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Sponsor: Ottawa Hospital Research Institute
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2700
Start Date
2021-02-10
Completion Date
2028-04
Last Updated
2026-01-15
Healthy Volunteers
No
Interventions
Rosuvastatin Calcium
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Placebo Oral Tablet
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Locations (31)
Foothills Medical Centre
Calgary, Alberta, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Hôpital Montfort
Ottawa, Ontario, Canada
Niagara Health - St. Catharines Site
St. Catharines, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill Univeristy Health Centre
Montreal, Quebec, Canada
CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
Montreal, Quebec, Canada
CHU de Quebec-Université Laval
Québec, Quebec, Canada
CHU d'Angers - Service d'accueil et traitement des Urgences
Angers, France
Brest University Hospital Centre
Brest, France
CHU de Clermont-Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, France
APHP Hôpital Louis Mourier
Colombes, France
CHU de Dijon - Service d'imagerie diagnostique et thérapeutique
Dijon, France
GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire
La Rochelle, France
Centre Hospitalier Universitaire De Saint Etienne
Saint-Etienne, France
CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse
Toulon, France
Mater Misericordiae University Hospital
Dublin, Ireland
University of Insubria
Varese, Italy
Ostfold Hopsital
Sarpsborg, Norway
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom