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

NCT ID: NCT04611386

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-08-01

Brief Summary

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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

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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.

Conditions

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Contrast Agents and Oral Factor Xa Inhibitor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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rivaroxaban group

20 rivaroxaban using patients

computerized tomography

Intervention Type DRUG

Anti Factor Xa level

apixaban group

20 apixaban using patients

computerized tomography

Intervention Type DRUG

Anti Factor Xa level

edoxaban group

20 edoxaban using patients

computerized tomography

Intervention Type DRUG

Anti Factor Xa level

control group

5 control group patients

computerized tomography

Intervention Type DRUG

Anti Factor Xa level

Interventions

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computerized tomography

Anti Factor Xa level

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Postgraduate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hasan ARI

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35296141 (View on PubMed)

Other Identifiers

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Bursa Yüksek İhtisas EAH

Identifier Type: -

Identifier Source: org_study_id