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Study Comparing Bleeding Risk of Rivaroxaban and Apixaban in Patients with Acute Venous Thromboembolism

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Acute Venous Thromboembolism (VTE), a condition where blood clots form in the veins, which can be serious if not treated properly. The study is comparing two medications, Rivaroxaban and Apixaban, both of which are used to prevent and treat blood clots. These medications are taken as film-coated tablets and work as antithrombotic agents, meaning they help reduce the formation of clots in the blood.

The purpose of the study is to compare the safety of these two medications in treating VTE. Participants in the study will be randomly assigned to receive either Rivaroxaban or Apixaban, or a placebo, and will take the medication orally for a period of up to three months. The study will monitor the occurrence of bleeding events, which are a potential side effect of these medications, to determine which treatment is safer.

Throughout the study, researchers will track various outcomes, including the rate of bleeding events, any recurrence of VTE, and overall survival rates. The study aims to provide valuable information on the safety and effectiveness of Rivaroxaban and Apixaban in treating acute venous thromboembolism, helping to guide future treatment decisions for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide informed consent, which means you agree to participate after understanding the study details.
A urine pregnancy test will be conducted for all females of childbearing potential to ensure eligibility.
Step 2
Medication assignment
You will be assigned to take either Xarelto or Eliquis for the treatment of acute venous thromboembolism.
Xarelto is available in two dosages: 15 mg and 20 mg, both taken orally as film-coated tablets.
Eliquis is available as a 5 mg film-coated tablet, also taken orally.
Step 3
Medication administration
If you are assigned Xarelto 15 mg, you will take it twice daily for the initial 21 days, followed by Xarelto 20 mg once daily.
If you are assigned Eliquis 5 mg, you will take it twice daily for the duration of the study.
Step 4
Regular follow-up visits
You will attend regular follow-up visits to monitor your health and any side effects. These visits are crucial for assessing the safety and effectiveness of the medication.
During these visits, you may be asked about any bleeding events or other symptoms you experience.
Step 5
Completion of study
The study is expected to end by September 30, 2024. Upon completion, you will have a final visit to discuss your experience and any ongoing care you may need.
Your participation will contribute to understanding the safety of the medications used in treating venous thromboembolism.

Who can join the trial?

5 criteria

Have **symptomatic acute VTE**: This means you have a sudden blockage in a vein, which could be a **deep vein thrombosis (DVT)** in the upper part of your leg or a **pulmonary embolism (PE)** that affects a significant part of your lung.
Be **18 years old or older**.
Be able to **understand the Patient Information Leaflet** and provide **signed and dated informed consent**. This means you understand the study details and agree to participate.
If you are a woman who can have children, you must be using **effective contraception** to prevent pregnancy during the study.
Have a **negative urine pregnancy test** at the first visit if you are a woman, even if you have irregular or no menstrual periods and are 55 years old or younger, unless you are permanently unable to have children.

Who cannot join the trial?

10 criteria

Patients with a history of **allergic reactions** to the study medications cannot participate. An allergic reaction is when your body reacts badly to a substance, causing symptoms like rash, itching, or difficulty breathing.
Patients who are currently taking other **blood thinners** cannot join the study. Blood thinners are medications that help prevent blood clots.
Patients with **severe liver disease** are excluded. Severe liver disease means the liver is not working properly, which can affect how medications are processed in the body.
Patients with **kidney problems** that require dialysis cannot participate. Dialysis is a treatment that does the work of the kidneys when they are not functioning well.
Pregnant or breastfeeding women are not allowed to join the study.
Patients with a history of **bleeding disorders** are excluded. Bleeding disorders are conditions that affect the way your blood clots, leading to excessive bleeding.
Patients who have had a recent **major surgery** are not eligible. Major surgery refers to significant operations that require a long recovery time.
Patients with **uncontrolled high blood pressure** cannot participate. Uncontrolled high blood pressure means that the blood pressure is consistently too high, even with medication.
Patients with a history of **stroke** are excluded. A stroke occurs when blood flow to a part of the brain is interrupted, causing brain cells to die.
Patients with **cancer** that is not in remission cannot join. Remission means that the signs and symptoms of cancer are reduced or have disappeared.

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Investigated drugs

Rivaroxaban
is a medication used to treat and prevent blood clots. It works by blocking certain proteins in your blood that are involved in the clotting process. This helps to reduce the risk of clots forming in your blood vessels, which can lead to serious conditions like deep vein thrombosis or pulmonary embolism. In this trial, rivaroxaban is being studied to see how safe it is compared to another medication for treating blood clots.
Apixaban
is another medication that helps prevent blood clots. Like rivaroxaban, it works by interfering with the blood's ability to clot. This can help prevent clots from forming in your veins, which can cause health problems if they travel to your lungs or other parts of your body. The trial is looking at how safe apixaban is compared to rivaroxaban when used to treat blood clots.

What is already known about the treatment

Rivaroxaban
Rivaroxaban is a medication taken orally, usually in the form of a tablet, and is used to treat and prevent blood clots, specifically in conditions like acute venous thromboembolism (VTE). It is well-documented in medical literature as an effective anticoagulant, meaning it helps prevent the formation of harmful blood clots. Rivaroxaban works by inhibiting a specific protein in the blood called Factor Xa, which is crucial in the blood clotting process. It belongs to a class of drugs known as direct oral anticoagulants (DOACs).
Apixaban
Apixaban is administered orally in tablet form and is used to treat and prevent blood clots, particularly in cases of acute venous thromboembolism (VTE). It is recognized in medical literature as a reliable anticoagulant, which means it helps reduce the risk of blood clots forming. Apixaban functions by blocking the activity of Factor Xa, a key protein in the blood clotting process. It is classified as a direct oral anticoagulant (DOAC).

Investigated diseases

Acute Venous Thromboembolism – Acute Venous Thromboembolism is a condition where blood clots form in the veins, often in the legs, and can travel to the lungs, causing a blockage. It typically begins with deep vein thrombosis, where clots develop in the deep veins of the legs. If a clot dislodges, it can move to the lungs, resulting in a pulmonary embolism. The progression involves swelling, pain, and redness in the affected limb, and if it reaches the lungs, it can cause chest pain and difficulty breathing. The condition can develop suddenly and requires prompt attention to prevent complications. It is a common vascular condition that can affect individuals of various ages and health backgrounds.