Study on the Effects of Apixaban Absorption in Patients Undergoing Roux-en-Y Gastric Bypass Surgery

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What is this study about?

This clinical trial is focused on patients who have undergone a Roux-en-Y gastric bypass, a type of weight-loss surgery. The study is examining how this surgery affects the absorption of a medication called Apixaban, which is a blood thinner used to prevent blood clots. The trial will also involve other medications, including Beriplex, Norit, and Ondexxya, which are used as reversal agents to counteract the effects of blood thinners.

The purpose of the study is to understand how the body processes Apixaban before and after the surgery. Participants will receive the medication and have their blood levels checked at different times: before the surgery, shortly after, and a few months later. This will help researchers see how the surgery impacts the medication’s effectiveness. The study will also monitor participants’ weight and body mass index (BMI) changes, as well as any major bleeding events or occurrences of blood clots, such as pulmonary embolism or deep vein thrombosis.

The study is expected to run until 2026, with recruitment starting in 2025. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on how Roux-en-Y gastric bypass surgery affects the absorption and effectiveness of Apixaban and other related medications.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that you are 18 years or older and have been approved for a laparoscopic gastric bypass surgery.

2 baseline measurement

Before the surgery, a baseline measurement of your blood levels will be taken. This involves measuring the Area Under the Curve (AUC) of anti-Xa levels, which helps in understanding how the medication apixaban is absorbed in your body.

3 surgery

You will undergo the Roux-en-Y gastric bypass surgery as planned. This is a surgical procedure to help with weight loss.

4 post-surgery medication

After the surgery, you will continue to take apixaban orally. The dosage and frequency will be as prescribed by your healthcare provider.

5 follow-up measurements

Follow-up measurements of the AUC of anti-Xa levels will be conducted at multiple time points: approximately 17 days after surgery, up to 60 days after surgery, and around 3 months after surgery. These measurements help in assessing the changes in medication absorption post-surgery.

6 weight and BMI check

At the 3-month follow-up visit, your weight and Body Mass Index (BMI) will be measured to evaluate the weight-loss effects of the surgery.

7 monitoring for side effects

Throughout the study, you will be monitored for any major bleeding events and the occurrence of venous thromboembolism (VTE), which includes conditions like pulmonary embolism and deep vein thrombosis.

Who Can Join the Study?

  • Patients who are screened and approved to undergo laparoscopic gastric bypass (a type of weight-loss surgery).
  • Age 18 years or older.

Who Cannot Join the Study?

  • Patients who have not undergone a Roux-en-Y gastric bypass surgery. This is a type of weight-loss surgery that changes the structure of the stomach and small intestine.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Axgvdzkda Uip Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.05.2025

Trial locations

Apixaban is a medication used to prevent blood clots. It is often prescribed to people who have conditions that increase their risk of developing clots, such as atrial fibrillation, a type of irregular heartbeat. In this clinical trial, the researchers are studying how the body absorbs and processes apixaban before and after a specific type of weight-loss surgery called Roux-en-Y gastric bypass. This surgery changes the digestive system, and the study aims to understand if and how it affects the way apixaban works in the body.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this results in an increase in body weight and body mass index (BMI). Obesity can progress gradually, often starting with weight gain and eventually leading to a state where the body has a high percentage of fat. It is associated with various metabolic changes and can contribute to the development of other health conditions. The progression of obesity can vary based on lifestyle, genetics, and environmental factors.

Trial ID:
2024-519737-30-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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