Statins for Venous Event Reduction in Patients With Venous Thromboembolism

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.

Conditions

• Venous Thromboembolism
• Blood Clot
• Post Thrombotic Syndrome

Interventions

DRUG

Rosuvastatin Calcium

Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.

DRUG

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Eastern Norway Health Authorities RHF

  collaborator UNKNOWN

• Southern health region, Norway

  collaborator UNKNOWN

• Programme hospitalier de recherche clinique, France

  collaborator UNKNOWN

• British Heart Foundation

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Aurélien Delluc, MD · Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-10

Primary Completion

2028-01-31

Completion

2028-04-30

Countries

• Canada
• France
• Ireland
• Italy
• Norway
• United Kingdom

Study Locations