The SAVER Trial: StAtins for Venous Event Reduction in Patients with Venous Thromboembolism
Summary
The SAVER Trial is a research study (trial) being conducted to determine if a cholesterol-lowering medication (statin) can help prevent blood clots in people with deep vein thrombosis or pulmonary embolism. 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. We also hope to discover if taking a statin reduces damage to your veins.
If you are eligible and consent to the trial, then you would be randomly assigned to take either a statin medication or a placebo. You will have follow-up phone calls or visits every 6 months, for a minimum of 6 months, up to a maximum of 5 years.
A member of the research team can provide more information about the trial if you are interested in hearing more.
Eligibility
Eligible ages: 19 to 100
Inclusion criteria:
We are recruiting anyone who are:
1) Greater than 18 years of age
2) Have been diagnosed with a deep vein thrombosis or pulmonary embolism within the last 30 days.
Exclusion criteria:
You are not eligible to participate if you are
1) 18 years of age or younger.
2) Unable or unwilling to provide written informed consent.
3) Not able to use contraception if you are a woman of childbearing age.
4) Currently taking a cholesterol statin medication.
5) Have a known medical history or current diagnosis of any of the following; diabetes, abdominal aortic aneurysm, peripheral arterial disease, stroke, transient ischemic attack, heart attack, other heart conditions, high cholesterol, unable to take rosuvastatin, or an unstable medical or psychological condition that would interfere with your ability to participate in the trial.
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
You may be approached in a clinic about this research study if you have had a recent blood clot in the legs or lungs. You can also contact the research team directly if you think you may be eligible and are interested in hearing more.
Principal investigator:
Leslie Skeith
Clinical trial:
Yes
REB-ID:
REB21-0176