RecruitingPHASE3INTERVENTIONAL

Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism

Doctors are studying if a medicine called omeprazole can lower the risk of bleeding from the stomach or gut in older adults. These adults are taking blood thinners because they have had a blood clot, such as in their leg or lung. Blood thinners are vital for treating clots but can sometimes increase the risk of bleeding, especially from the stomach. Omeprazole is a common medicine that reduces stomach acid. This first study is a 'pilot' to check if a larger study would work well. It helps researchers understand if enough people would want to take part and if the study steps are practical.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ottawa Hospital Research Institute

Enrolment target

360

Start

06 Nov 2024

Estimated completion

01 Mar 2028

Venous Thromboembolism Gastro Intestinal Bleeding Blood Clot

What is this study about?

When you have a blood clot, for example, in your leg (deep vein thrombosis) or lung (pulmonary embolism), doctors often prescribe medicines called 'blood thinners' (anticoagulants). These medicines are very important to treat the clot and stop new ones from forming. However, a common side effect of blood thinners is an increased risk of bleeding. This bleeding often happens in the stomach or gut.

This study is looking at whether a medicine called omeprazole can help reduce this risk of stomach or gut bleeding. Omeprazole is a well-known medicine that works by reducing the amount of acid in your stomach. While omeprazole is already approved for conditions like heartburn or stomach ulcers, its use for preventing bleeding in people on blood thinners is still being investigated. The study aims to see if giving omeprazole alongside blood thinners can make treatment safer for people at risk of stomach bleeding.

This is a 'pilot' study, which means it's a smaller, early-stage study. Its main goal isn't to give a final answer but to check if a larger, more comprehensive study would be possible and practical. Researchers want to make sure they can find enough participants and that the study procedures work smoothly. Participants will either receive omeprazole or a placebo (a dummy pill with no active medicine) to help researchers get clear and reliable results. The placebo will not affect bleeding in any way.

Key takeaways

This study looks at reducing stomach bleeding in older people on blood thinners.
It tests if omeprazole, a stomach acid reducer, can help.
Participation involves taking omeprazole or a dummy pill (placebo).
It's a pilot study to plan a larger trial.
The study lasts at least 3 months with regular check-ups.

Who may be eligible?

To be considered for this study, you need to be 65 years old or older. You must have been recently diagnosed with a blood clot in a vein (like in your leg, arm, or lung) and be planning to take blood thinners for at least three months. You also need to be able to attend follow-up appointments.

You would not be able to join if you have already been taking blood thinners for more than seven days before the study starts. You also can't take part if you are already regularly taking omeprazole or similar stomach acid-reducing medicines every day, or if you've had a serious bleed from your stomach or gut before. People who need certain other blood-thinning medicines, or have a severe allergy or other serious health issue linked to omeprazole, would also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 65 years old or older?
Have you recently been diagnosed with a blood clot in a vein?
Are you starting blood thinner medication soon (or within the last 7 days)?
Are you able to attend follow-up appointments?
Do you *not* regularly take omeprazole or a similar daily stomach acid medicine already?
Have you *not* had a serious bleed from your stomach or gut in the past?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have an initial assessment to see if you are suitable. If you are, you would be randomly assigned to take either omeprazole tablets or a placebo tablet (which looks the same but has no active medicine). You would take this study medicine once a day. The study will last for at least three months, which is the period when you are most at risk of bleeding after starting blood thinners. During this time, you would have regular check-ups with the study team to monitor your health and any side effects. These check-ups might involve appointments or phone calls. The total duration of your involvement in the study would be at least three months, or potentially longer depending on your treatment plan.

Potential risks and benefits

Taking part in this study might offer the potential benefit of reducing your risk of stomach bleeding while on blood thinners. However, because this is an investigational study, we don't yet know for sure if omeprazole is effective for this purpose. There are potential risks associated with taking any medication, including omeprazole, such as side effects (though these are generally mild). You will receive careful monitoring throughout the study. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (7)

The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting
Niagara Health System - St. Catharines Site
Verified postcode
St. Catharines, Canada· Not yet recruiting
University Health Network - Toronto General
Verified postcode
Toronto, Canada· Recruiting
CIUSSS de l'Est-de- l'Île-de-Montréal
Verified postcode
Montreal, Canada· Not yet recruiting
Centre hospitalier de l'Université de Montréal
Verified postcode
Montreal, Canada· Recruiting
CHU de Québec-Université Laval; Hôpital Saint-François d'Assise
Verified postcode
Québec, Canada· Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What is a 'blood thinner'?

Blood thinners are medicines that help prevent blood clots from forming or getting bigger. They are officially called 'anticoagulants'.

What is omeprazole?

Omeprazole is a common medicine that helps reduce the amount of acid in your stomach. It's often used for heartburn or stomach ulcers.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but doesn't contain any active ingredients. It's used to help scientists compare the real medicine's effects more clearly.

Why are older people being chosen for this study?

Older adults are chosen because they naturally have a higher risk of bleeding when taking blood thinners. This helps the researchers focus on a group who might benefit most.

Is omeprazole already approved for preventing bleeding from blood thinners?

No, not currently. While omeprazole is approved for other stomach conditions, its use for preventing bleeding in people on blood thinners is still being studied and is not yet approved in Canada (where this trial is taking place).

How to find out more

Deborah Siegal, MD

dsiegal@toh.ca (613) 737-8899 Official trial record

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