Ongoing, recruitingTherapeutic use (Phase IV)Interventional

COmparison of Bleeding Risk between Rivaroxaban and Apixaban for the treatment of acute venous thromboembolism

This study, called COmparison of Bleeding Risk between Rivaroxaban and Apixaban, looks at two widely used blood-thinning medicines, Rivaroxaban (also known as Xarelto) and Apixaban (also known as Eliquis). Both are prescribed to treat blood clots in the veins, a condition called acute venous thromboembolism. The main goal is to find out which of these medicines causes fewer problems with bleeding that are serious enough to be a concern, whether they are major bleeding events or other clinically relevant bleeding. The study is for people already taking these medicines, checking how they work in real life. It also looks at other things like how well the medicines prevent new clots, how long people live, and the cost-effectiveness of each treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Royal College Of Surgeons In Ireland

Enrolment target

Start

23 Jun 2023

Acute Venous Thromboembolism

What is this study about?

This study is looking at two common medicines, Xarelto (rivaroxaban) and Eliquis (apixaban), which are both used to treat blood clots in the veins (a condition called acute venous thromboembolism). These medicines are known as 'blood thinners' because they help stop blood from clotting too easily. While they are very good at treating clots, a common side effect of all blood thinners is that they can increase your risk of bleeding.

The main purpose of this research is to compare Xarelto and Eliquis to see if one causes fewer serious bleeding issues than the other. This includes both major bleeding events and other types of bleeding that are important for doctors to monitor. The study is a 'Phase IV' study, which means it's happening after these medicines have already been approved and are being used by patients. It helps doctors understand how these treatments work in a wide range of real-world situations.

By carefully comparing these two medicines, doctors hope to gain a clearer picture of their benefits and risks. This information can then help them make the best choices for patients needing treatment for blood clots, aiming to reduce serious side effects like bleeding while still effectively treating their condition.

Key takeaways

The study compares two common blood clot medicines: Xarelto and Eliquis.
The main focus is to see which medicine causes fewer significant bleeding problems.
It's for adults already taking one of these medications for blood clots.
Participation involves monitoring your health as part of your ongoing care.
The goal is to help doctors make better choices for future patients.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of all adult ages can potentially join.

Both men and women are welcome to participate. The study is open to anyone who fits the age criteria, regardless of their gender.

Essentially, if you are an adult and have been diagnosed with acute venous thromboembolism (blood clots) and are being treated with either Rivaroxaban (Xarelto) or Apixaban (Eliquis), you might be able to take part in this research.

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 18 years old or older?
Do you currently have blood clots (venous thromboembolism)?
Are you being treated with either Rivaroxaban (Xarelto) or Apixaban (Eliquis)?
Are you happy for information about your health to be used for research?

Answer every question to see your result.

What does participation involve?

This study is designed to observe how Xarelto and Eliquis work in patients already receiving them, so it largely involves collecting information from your usual medical care, rather than adding many extra appointments. You would continue taking your prescribed blood-thinning medication (either Xarelto or Eliquis) as usual. Researchers would carefully monitor any bleeding events you experience, along with other health outcomes. The specific details of follow-up visits would align with your standard treatment plan, and your health data would be collected over time. The total duration of your participation would depend on how long you are on the medication and how long the study continues to monitor patients, but it's generally about observing your health journey while on these treatments.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand more about these common blood-thinning medicines, which could improve care for future patients with blood clots. There are no direct personal benefits from participating beyond your current medical care, as you would continue your prescribed treatment. The main risk involved with these medicines is bleeding, which is a known side effect that your doctors already monitor. Participating in the study means this monitoring would be part of a research effort to collect data. Remember, you can choose to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Ireland

Common questions

What are acute venous thromboembolism (VTE) and blood clots?

Acute venous thromboembolism, often called VTE, is a medical term for blood clots that form in your veins. These clots can be serious, and medicines like Xarelto and Eliquis help prevent them from growing or causing more problems.

What does 'clinically relevant bleeding' mean?

This means any bleeding that is serious enough for a doctor to consider important. It includes both major bleeding (very serious) and other types of bleeding that might not be life-threatening but still need medical attention or cause discomfort.

Are Xarelto and Eliquis new medicines?

No, both Xarelto (rivaroxaban) and Eliquis (apixaban) have been approved and are commonly prescribed for treating blood clots. This study is looking at how they perform in real-world patients.

Will taking part change my actual medical treatment?

No, your medical team will continue to manage your treatment for blood clots as they usually would. This study is about observing and collecting information on patients already receiving these treatments.

What is 'Phase IV' in a clinical trial?

Phase IV studies happen after a medicine has been approved and is widely available. They help gather even more information about the medicine's safety, side effects, and long-term effects when used by many different types of people in everyday healthcare.