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Obesity effect on the characteristics of the blood-thinning drug rivaroxaban

The Effect of Obesity on the Pharmacokinetic and Pharmacodynamic Disposition of Rivaroxaban in Patients with Venous Thromboembolism (VTE) or Non-valvular Atrial Fibrillation (AF)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000297729
Acronym
EPHORIA
Enrollment
2
Registered
2022-02-16
Start date
2021-11-17
Completion date
2022-12-31
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research is being conducted to investigate the effect of body weight on the characteristics (mainly the plasma drug concentration) of a blood-thinning drug known as rivaroxaban. This drug is used for the treatment of blood clots, and for the prevention of stroke in a certain heart-related disease known as Atrial Fibrillation. Participants in this research will provide blood samples during their enrollment period, and these samples will be used to quantify drug concentration in patients with body weight greater than 120 kg or BMI of greater than or equal to 40 kg/m2 , in order to compare that to non-morbidly obese patients.

Interventions

Rivaroxaban is the exposure drug. If the primary physician decided to start the patient on rivaroxaban, they will be screened for enrollment in this study. It will be prescribed and administered to morbidly obese patients (body weight >120 kg or BMI of 40 kg/m2 or more, and patients with BMI 30 to <35 kg/m2 ) who present with venous thromboembolisms (including deep vein thrombosis or pulmonary embolisms) or atrial fibrillation if no contraindications exist. We will draw blood samples at differ

Rivaroxaban is the exposure drug. If the primary physician decided to start the patient on rivaroxaban, they will be screened for enrollment in this study. It will be prescribed and administered to morbidly obese patients (body weight >120 kg or BMI of 40 kg/m2 or more, and patients with BMI 30 to <35 kg/m2 ) who present with venous thromboembolisms (including deep vein thrombosis or pulmonary embolisms) or atrial fibrillation if no contraindications exist. We will draw blood samples at different time-points starting pre-dose and up to 96 hours after the first dose to measure the drug concentration at the blood and draw the area under the curve (AUC) graph for morbidly obese vs. the control group. In addition to comparing drug concentration among groups, we will also explore the difference in the pharmacodynamics of the drug as well as any genetic polymorphisms that might explain any differences. Rivaroxaban dose is 15 mg oral tablet twice daily for 21 days then 20 mg oral tablet once daily thereafter for the treatment of acute venous thromboembolism. However, patients will be recruited to this study for up to 96 hours only. The total duration of treatment will depend on the medical condition and patient comorbidities and will be decided by the primary physicians. Dose for non-valvular atrial fibrillation is 20 mg tablet orally once daily.

Sponsors

Medical Research Center, Hamad Medical Corporation
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adults with age greater than or equal to 18 years • Diagnosis of DVT, PE, or non-valvular atrial fibrillation • Admission to medical ward or emergency department in Hamad General Hospital • Eligibility for rivaroxaban treatment

Exclusion criteria

• Abnormal kidney function (CrCl of less than 30 ml/min) • Severe liver disease • Valvular heart disease • Hemodynamic instability or current admission to intensive care units • Active bleeding or high bleeding risk • Patients with extremely low weight (less than 50 kg) • Antiphospholipid antibody syndrome • Any other contraindications to rivaroxaban

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026