NCT04611386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 27, 2020

Last Update Submit

October 27, 2020

Conditions

Contrast Agents and Oral Factor Xa Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Anti Factor Xa level

    14 days

Study Arms (4)

rivaroxaban group

20 rivaroxaban using patients

Drug: computerized tomography

apixaban group

20 apixaban using patients

Drug: computerized tomography

edoxaban group

20 edoxaban using patients

Drug: computerized tomography

control group

5 control group patients

Drug: computerized tomography

Interventions

computerized tomographyDRUG

Anti Factor Xa level

apixaban groupcontrol groupedoxaban grouprivaroxaban group

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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. -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

Location

Related Publications (1)

  • Cavlan B, Ari S, Ari H, Camci S, Melek M, Bozat T. The effect of contrast agents on the anticoagulant properties of oral factor Xa inhibitors. Acta Radiol. 2023 Feb;64(2):588-595. doi: 10.1177/02841851221081474. Epub 2022 Mar 16.

    PMID: 35296141DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

November 2, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)