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

Contrast Agents and Oral Factor Xa Inhibitor Clinical Trial

Official title:

Bursa Postgraduate Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611386
• Other study ID #: Bursa Yüksek Ihtisas EAH
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2020
• Source: Bursa Postgraduate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Contrast Agents and Oral Factor Xa Inhibitor

Intervention

Drug:
• computerized tomography
Anti Factor Xa level

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti Factor Xa level		14 days