Blood thinner study targets dosing mystery in obesity and bariatric patients
NCT ID NCT04180436
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how the blood thinner rivaroxaban behaves in people with severe obesity or after bariatric surgery (gastric bypass or sleeve gastrectomy). Researchers gave 67 participants rivaroxaban daily for 8 days and measured drug levels and blood clotting. The goal is to understand if obesity or surgery changes how the drug works, which could help doctors choose safer doses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivaroxaban (a blood thinner)
- What this could lead to
- If successful, this study could help doctors adjust blood thinner doses for people with severe obesity or after weight-loss surgery, reducing clot risk.
- What could go wrong
- This is a small, early-phase study focused on drug levels, not on preventing clots or bleeding. Results may not change practice without larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
67 people
The number who actually took part.
- Started
-
Jan 2020
- Finished
-
Jun 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Creatinine clearance measured by the Cockroft formula ≥ 60 mL / min * Patient meeting the specific criteria of one of the 4 groups: * morbidly obese patients with BMI ≥ 40 * Patients operated by gastric bypass for over a year and with stable weight * Patients operated by sleeve gastrectomy for over a year and with stable weight * Control group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups. Exclusion Criteria: * Indication for anticoagulant therapy, antiplatelet therapy or long-term nonsteroidal anti-inflammatory drugs * Clinically significant bleeding in progress * Taking oral or parenteral anticoagulants, or taking platelet antiaggregants within 4 weeks before inclusion * Congenital or acquired hemorrhagic disorders (eg von Willebrand disease, hemophilia) * Injury or disease, at significant risk of major bleeding (gastrointestinal ulceration, presence of malignant tumors with a high risk of bleeding, recent brain or spinal cord injury, recent cerebral, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected oesophageal varices , arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities) * Severe uncontrolled arterial hypertension * Active gastrointestinal disease potentially leading to bleeding disorders (esophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel disease) * Vascular retinopathy * Bronchiectasis or history of pulmonary bleeding * Hypersensitivity to the active substance or to any of the excipients of rivaroxaban * Hepatic involvement associated with coagulopathy and clinically significant bleeding risk, including cirrhotic patients with Child Pugh Grade B or C score * Concomitant use of potent inhibitors or inducers of CYP3A4 and / or P-gp (azole antifungal or HIV protease inhibitor) * Participation in a paid and / or therapeutic study in the previous 3 months * Pregnant or lactating women, * Women of childbearing potential not using effective contraception
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHRU de Brest
Brest, France, 29609, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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