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Completed

NCT Number: NCT04611386

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

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • coagulopathy,
  • severe hepatic insufficiency,
  • chronic systemic or inflammatory diseases,
  • patients lighter than 60 kg,
  • malignancy,
  • creatinine value above 1.5 mg/dl, and
  • not providing consent to participate in the study -

Treatment and study plan

computerized tomography

Drug

Anti Factor Xa level

Primary outcomes

  1. Anti Factor Xa level

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Bursa Postgraduate Hospital

Other

Registry information

Official study title

Bursa Postgraduate Hospital

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2020
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.