Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Who is this study for? Patients with venous thromboembolism
What treatments are being studied? Rosuvastatin Calcium
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Foothills Medical Centre
RECRUITING
Calgary
Queen Elizabeth II Hospital
WITHDRAWN
Halifax
Hamilton General Hospital
RECRUITING
Hamilton
Juravinski Hospital
RECRUITING
Hamilton
St. Joseph's Healthcare
RECRUITING
Hamilton
CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
McGill Univeristy Health Centre
RECRUITING
Montreal
Hôpital Montfort
WITHDRAWN
Ottawa
The Ottawa Hospital
RECRUITING
Ottawa
CHU de Quebec-Université Laval
RECRUITING
Québec
Niagara Health - St. Catharines Site
RECRUITING
St. Catharines
Sunnybrook Hospital
NOT_YET_RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
France
Brest University Hospital Centre
NOT_YET_RECRUITING
Brest
Ireland
Mater Misericordiae University Hospital
NOT_YET_RECRUITING
Dublin
Italy
University of Insubria
NOT_YET_RECRUITING
Varese
Norway
Ostfold Hopsital
RECRUITING
Sarpsborg
Contact Information
Primary
Jennifer Brinkhurst
jbrinkhurst@ohri.ca
+16137378899
Time Frame
Start Date: 2021-02-10
Estimated Completion Date: 2028-04
Participants
Target number of participants: 2700
Treatments
Experimental: Rosuvastatin
Participants randomized to the experimental arm will take one rosuvastatin 20 mg tablet by mouth every day for the duration of their participation in the study.
Placebo_comparator: Placebo
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov