The Effect of Contrast Agents on the Anticoagulant Properties of Oral Factor Xa Inhibitors

Completed

• Conditions: Contrast Agents and Oral Factor Xa Inhibitor
• Interventions: Drug: computerized tomography

• Registration Number: NCT04611386
• Lead Sponsor: Bursa Postgraduate Hospital

Brief Summary

The aim of this study is to evaluate the effect of iohexol as a contrast agent on the anticoagulant activity of oral factor Xa inhibitors.

Detailed Description

The study included 65 people who underwent contrast computerized tomography (CT). The study patients were divided into 4 groups. Patients in group 1 were using rivaroxaban (20 patients), patients in group 2 were using apixaban (20 patients), patients in group 3 were using edoxaban (20 patients), and group 4 was the control group (5 volunteers). Iohexol (60 ml) was used as a contrast agent. Two tubes were used to collect 2 ml of blood from the patients at 4 hours after the drug dose (rivaroxaban, apixaban, or edoxaban) and 1 hour after the contrast CT (CT was performed 3 hours after the drug was taken). In the control group, at any time and 1 hour after contrast CT, 2 tubes of 2 ml of blood were collected. The anticoagulant properties of rivaroxaban, apixaban, and edoxaban were evaluated using anti-factor Xa levels.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. the use of oral factor Xa inhibitors (patients with nonvalvular AF and CHA2DS2-VASc Score ≥2),
2. age of 21-80 years,
3. no contraindications for anticoagulation use,
4. GFR greater than 30,
5. volunteering to participate in the study, and
6. patients who needed to use contrast agent (iohexol) for CT examination. -

Exclusion Criteria

1. coagulopathy,
2. severe hepatic insufficiency,
3. chronic systemic or inflammatory diseases,
4. patients lighter than 60 kg,
5. malignancy,
6. creatinine value above 1.5 mg/dl, and
7. not providing consent to participate in the study -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rivaroxaban group	computerized tomography	20 rivaroxaban using patients
apixaban group	computerized tomography	20 apixaban using patients
edoxaban group	computerized tomography	20 edoxaban using patients
control group	computerized tomography	5 control group patients

Primary Outcome Measures

Name	Time	Method
Anti Factor Xa level	14 days

Trial Locations

Locations (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi; 🇹🇷 Bursa, Turkey