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

October 27, 2020 updated by: Hasan ARI, Bursa Postgraduate Hospital

Bursa Postgraduate Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study prospectively included 65 people who underwent contrast computerized tomography (CT). The CT indications were thoracic aortic dilatation, chronic obstructive pulmonary disease, abdominal aortic dilatation, chronic abdominal pain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rivaroxaban group
20 rivaroxaban using patients
Drug: computerized tomography
Anti Factor Xa level
apixaban group
20 apixaban using patients
Drug: computerized tomography
Anti Factor Xa level
edoxaban group
20 edoxaban using patients
Drug: computerized tomography
Anti Factor Xa level
control group
5 control group patients
Drug: computerized tomography
Anti Factor Xa level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti Factor Xa level
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Postgraduate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (ACTUAL)

November 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Bursa Yüksek Ihtisas EAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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