Contrast Agents and Oral Factor Xa InhibitorNCT04611386
The Effect of Contrast Agents on the Anticoagulant Properties of Oral Factor Xa Inhibitors
An observational study of Contrast Agents and Oral Factor Xa Inhibitor, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Contrast Agents and Oral Factor Xa Inhibitor
- What is being tested?
- computerized tomography
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Aug 2019
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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. -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa
About this study
Official title: 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.
Read the 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.
- Being tested
- computerized tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized tomographyDrug
Anti Factor Xa level
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban group | 20 rivaroxaban using patients Receives: Drug: computerized tomography | |
| apixaban group | 20 apixaban using patients Receives: Drug: computerized tomography | |
| edoxaban group | 20 edoxaban using patients Receives: Drug: computerized tomography | |
| control group | 5 control group patients Receives: Drug: computerized tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Factor Xa level
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Agents and Oral Factor Xa InhibitorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611386
- Sponsor's protocol ID
- Bursa Yüksek İhtisas EAH
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35296141
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bursa Postgraduate Hospital
- ClinicalTrials.gov ID
- NCT04611386
- Acronym / sponsor ID
- Bursa Yüksek İhtisas EAH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban group | – | Drug: computerized tomography20 rivaroxaban using patients |
| apixaban group | – | Drug: computerized tomography20 apixaban using patients |
| edoxaban group | – | Drug: computerized tomography20 edoxaban using patients |
| control group | – | Drug: computerized tomography5 control group patients |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- coagulopathy,
- severe hepatic insufficiency,
- chronic systemic or inflammatory diseases,
- patients lighter than 60 kg,
- malignancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized tomographyAnti Factor Xa level | Drug | apixaban group, control group, edoxaban group, rivaroxaban group |
Primary outcome
Anti Factor Xa level
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 35296141Cavlan 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Agents and Oral Factor Xa Inhibitor, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Factor Xa level (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.