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Blood thinner study targets dosing mystery in obesity and bariatric patients

NCT ID NCT04180436

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.