RecruitingPHASE3INTERVENTIONAL

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

This research is investigating if a medicine called a statin, usually used to lower cholesterol, can help people who have had a blood clot (like deep vein thrombosis or pulmonary embolism). Currently, these blood clots are treated with medicines that thin the blood. Some early research suggests that adding a statin, specifically rosuvastatin, might offer extra protection by stopping new clots from forming and reducing damage to your veins. Rosuvastatin is approved for cholesterol in Canada but is being tested here for blood clots. The study aims to see if combining rosuvastatin with your usual blood thinners is more effective than blood thinners alone. Half of the participants will receive rosuvastatin, and the other half will receive a 'dummy' pill (placebo) to ensure fair results.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ottawa Hospital Research Institute

Enrolment target

2,700

Start

10 Feb 2021

Estimated completion

01 Apr 2028

Venous Thromboembolism Blood Clot Post Thrombotic Syndrome

What is this study about?

If you've had a blood clot, such as a deep vein thrombosis (DVT) in your leg or a pulmonary embolism (PE) in your lung, you'll know that the usual treatment involves taking blood thinners. These medicines are very good at dealing with existing clots and preventing new ones.

However, scientists are always looking for ways to improve treatments. Some studies have hinted that adding a type of medicine called a statin might offer even more protection. Statins are usually known for lowering cholesterol levels, but they might also help the tiny cells lining your veins control inflammation, which could stop new clots from forming.

This study wants to find out if adding a specific statin, called rosuvastatin, to your regular blood thinner treatment can lower your chances of getting another blood clot. It also aims to see if rosuvastatin can help reduce any damage to your veins that might have occurred from the original clot. You might receive rosuvastatin or a placebo (a pill that looks the same but has no active medicine) to fairly compare the effects.

Key takeaways

This study explores a potential new way to prevent blood clots.
It tests if a statin (rosuvastatin) can add to the benefits of usual blood thinning medicines.
Some participants will receive the statin, others a dummy pill (placebo).
Rosuvastatin is currently used for cholesterol, not yet specifically for blood clots.
The aim is to reduce new clots and protect vein health.

Who may be eligible?

To join this study, you must have been diagnosed with a DVT (a blood clot in your leg) or a PE (a blood clot in your lung) within the last month. You need to be 18 years old or older.

There are several reasons why you might not be able to take part. For example, you can't join if you're already taking a statin, or if you have certain medical conditions like diabetes, a previous stroke, heart attack, or unstable angina, as statins are already recommended for these, and it would make it harder to see what the statin does for blood clots. You also can't participate if you have severe kidney or liver disease, are pregnant or breastfeeding, or if you're taking certain specific medicines that can react badly with rosuvastatin.

Quick self-check

Have I been diagnosed with a DVT or PE in the last month?
Am I 18 years old or older?
Am I currently *not* taking a statin for conditions like high cholesterol, diabetes, or heart disease?
Do I have any serious kidney or liver problems?
Am I pregnant or breastfeeding, or could I become pregnant during the study?
Am I taking any specific medications that might react badly with statins?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be given either rosuvastatin or a placebo pill (a dummy pill with no active medicine) to take alongside your usual blood thinners. The study team will explain how and when to take these. You will have regular appointments where the doctors and nurses will check on your health and any side effects. They will also carry out tests to see if the treatment is working and to monitor your veins. We don't have the exact duration of the study here, but similar trials often run for several months to a year or more, with follow-up appointments. You will be fully informed of the schedule at the start.

Potential risks and benefits

Taking part in this study could potentially offer an additional benefit by reducing your risk of future blood clots or vein damage, though this is not guaranteed as it's still being investigated. As with any medication, there's always a possibility of side effects from rosuvastatin, which the study team will monitor closely. Taking a placebo has no direct medicinal risks. You will be given full information on potential side effects before you decide to join. Remember, taking part is voluntary, and you can withdraw from the study at any time without affecting your usual medical care.

Locations (31)

Foothills Medical Centre
Calgary, Canada· Recruiting
Queen Elizabeth II Hospital
Halifax, Canada· Withdrawn
Hamilton General Hospital
Hamilton, Canada· Recruiting
St. Joseph's Healthcare
Hamilton, Canada· Recruiting
Juravinski Hospital
Hamilton, Canada· Withdrawn
The Ottawa Hospital
Ottawa, Canada· Recruiting
Hôpital Montfort
Ottawa, Canada· Withdrawn
Niagara Health - St. Catharines Site
St. Catharines, Canada· Recruiting
Sunnybrook Hospital
Toronto, Canada· Not yet recruiting
University Health Network
Toronto, Canada· Recruiting
Jewish General Hospital
Montreal, Canada· Recruiting
McGill Univeristy Health Centre
Montreal, Canada· Recruiting

+19 more sites — see the official record for the full list.

Common questions

What is a 'statin'?

Statins are medicines often prescribed to help lower cholesterol in your blood. In this study, we're seeing if they can also help prevent blood clots.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps us compare the effects of the actual drug fairly.

Why is rosuvastatin considered 'investigational' for blood clots?

Rosuvastatin is approved for lowering cholesterol, but it hasn't been officially approved specifically as a treatment for blood clots yet. This study is researching if it can be used for that purpose.

Will I know if I'm getting the statin or the placebo?

No, during the study, neither you nor the study doctors will know whether you are receiving the statin or the placebo. This helps ensure the results are unbiased and accurate.

What are the main goals of this study?

The study mainly wants to find out if adding rosuvastatin to standard blood thinner treatment reduces the chance of getting another blood clot, and if it helps protect your veins.

How to find out more

Jennifer Brinkhurst

jbrinkhurst@ohri.ca 613-737-8899 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.