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

Not Applicable

Recruiting

• Conditions: venous thromboembolism; atrial fibrillation; obesity; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Metabolic and Endocrine - Other metabolic disorders; Blood - Clotting disorders; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12622000297729
• Lead Sponsor: Medical Research Center, Hamad Medical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-16
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (Cmax, AUC, t1/2) of rivaroxaban assessed using blood samples withdrawn starting pre-dose and up to 12 hours post dose.[Predose, and at 1, 2, 4, 8, and 12 hours post-dose.]

Secondary Outcome Measures

Name	Time	Method
The pharmacodynamic parameters (factor Xa activity) of rivaroxaban assessed using blood samples at 96 hours post dose.[At 96 hours post-dose.]