Actively Recruiting
Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Led by Ottawa Hospital Research Institute · Updated on 2026-01-15
2700
Participants Needed
31
Research Sites
372 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic, confirmed proximal leg deep vein thrombosis or segmental or larger pulmonary embolism diagnosed within the last 30 days
You will not qualify if you...
- Unable or unwilling to provide written informed consent
- Younger than 18 years old
- Women of childbearing potential not using appropriate contraception
- Currently prescribed a statin medication
- Known history or current diagnosis of conditions requiring statins for secondary prevention including diabetes, abdominal aortic aneurysm, peripheral arterial disease, stroke, transient ischemic attack, myocardial infarction, acute coronary syndromes, stable or unstable angina, or arterial revascularization
- Known diagnosis of high cholesterol or dyslipidemia
- Contraindications to rosuvastatin such as allergy or intolerance to statins, muscle disorders or statin-related muscle pain, active liver disease, severe kidney disease (creatinine clearance less than 30 ml/min), pregnancy or breastfeeding, or use of certain medications (cyclosporine, atazanavir/ritonavir, darolutamide, regorafenib)
- Unstable medical or psychological condition that would interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
2
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9
Withdrawn
3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
4
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
5
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
Withdrawn
6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
7
Hôpital Montfort
Ottawa, Ontario, Canada, K1K 0T2
Withdrawn
8
Niagara Health - St. Catharines Site
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
9
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
Not Yet Recruiting
10
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
11
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
12
McGill Univeristy Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
13
CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
Montreal, Quebec, Canada, H9R 2Y2
Actively Recruiting
14
CHU de Quebec-Université Laval
Québec, Quebec, Canada, G1V 4G2
Actively Recruiting
15
CHU d'Angers - Service d'accueil et traitement des Urgences
Angers, France
Actively Recruiting
16
Brest University Hospital Centre
Brest, France
Actively Recruiting
17
CHU de Clermont-Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, France
Actively Recruiting
18
APHP Hôpital Louis Mourier
Colombes, France
Actively Recruiting
19
CHU de Dijon - Service d'imagerie diagnostique et thérapeutique
Dijon, France
Actively Recruiting
20
GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire
La Rochelle, France
Actively Recruiting
21
Centre Hospitalier Universitaire De Saint Etienne
Saint-Etienne, France
Actively Recruiting
22
CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse
Toulon, France
Actively Recruiting
23
Mater Misericordiae University Hospital
Dublin, Ireland
Not Yet Recruiting
24
University of Insubria
Varese, Italy
Not Yet Recruiting
25
Ostfold Hopsital
Sarpsborg, Norway
Actively Recruiting
26
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Not Yet Recruiting
27
Queen Elizabeth Hospital
Birmingham, United Kingdom
Not Yet Recruiting
28
University Hospital of Wales
Cardiff, United Kingdom
Not Yet Recruiting
29
Glasgow Royal Infirmary
Glasgow, United Kingdom
Not Yet Recruiting
30
King's College Hospital NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
31
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Not Yet Recruiting
Research Team
J
Jennifer Brinkhurst
CONTACT
O
OHRI Clinical Research Quality Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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