Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04319627

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic, confirmed proximal leg deep vein thrombosis or segmental or larger pulmonary embolism diagnosed within the last 30 days
Not Eligible

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

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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

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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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