Coronary Artery DiseaseNCT05541757
Rivaroxaban - Percutaneous Coronary Intervention
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation
- What is being tested?
- In vitro heparin
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Mar 2022
- 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 18 to 74 years
- All sexes
- Adult, Older adult
Study population: patients with persistent or permanent AF had been using rivaroxaban 20 mg daily for at least one month
Who may be able to join
- patients using the direct oral factor Xa inhibitor rivaroxaban
- Atrial fibrillation
Who cannot join
- malignancy,
- coagulopathy,
- heart valve disease,
- active infection,
- chronic systemic or inflammatory disease,
- recent ACS or elective PCI,
Show all 14Show fewer
- uncontrolled hypertension and diabetes,
- cerebrovascular accident,
- thyroid disorder,
- left ventricular systolic dysfunction (ejection fraction <50%),
- glomerular filtration rate <50 mL/min/1.73 m2,
- underweight and overweight (<60 kg and >100 kg),
- age >75 years,
- hyperbilirubinemia and hypertriglyceridemia (>350 mg/dl).
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: In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients
We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Being tested
- In vitro heparin
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro heparinDrug
In vitro heparin and in vitro LMWH
| Study group | Role | What they receive |
|---|---|---|
| control group | five healthy adults Receives: Drug: In vitro heparin | |
| Study group | Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban Receives: Drug: In vitro heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticoagulation level
anti-factor Xa
Measured: 4 - 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
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 Coronary Artery DiseaseStudies 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
- 30 participants (actual)
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
- NCT05541757
- Sponsor's protocol ID
- BYİEAH4
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Melek M, Ari H, Ari S, Cilgin MC, Yarar M, Huysal K, Agca FV, Bozat T. In vitro evaluation of anticoagulant therapy management when urgent percutaneous coronary intervention is required in rivaroxaban-treated patients. Naunyn Schmiedebergs Arch Pharmacol. 2023 Nov;396(11):3221-3232. doi: 10.1007/s00210-023-02533-2. Epub 2023 May 20.
PubMed 37209152
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients
- ClinicalTrials.gov ID
- NCT05541757
- Acronym / sponsor ID
- BYİEAH4
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 15 Sep 2022 (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.
We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Drug: In vitro heparinfive healthy adults |
| Study group | – | Drug: In vitro heparinTwenty-five patients using the direct oral factor Xa inhibitor rivaroxaban |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with persistent or permanent AF had been using rivaroxaban 20 mg daily for at least one month
Key inclusion criteria (2 listed)
- patients using the direct oral factor Xa inhibitor rivaroxaban
- Atrial fibrillation
Key exclusion criteria (14 listed)
- malignancy,
- coagulopathy,
- heart valve disease,
- active infection,
- chronic systemic or inflammatory disease,
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 |
|---|---|---|
| In vitro heparinIn vitro heparin and in vitro LMWH | Drug | Study group, control group |
Primary outcome
Anticoagulation level
Time frame: 4 - 12 hours
anti-factor Xa
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 15 Sep 2022.
- Derived from this study: PubMed 37209152Melek M, Ari H, Ari S, Cilgin MC, Yarar M, Huysal K, Agca FV, Bozat T. In vitro evaluation of anticoagulant therapy management when urgent percutaneous coronary intervention is required in rivaroxaban-treated patients. Naunyn Schmiedebergs Arch Pharmacol. 2023 Nov;396(11):3221-3232. doi: 10.1007/s00210-023-02533-2. Epub 2023 May 20.
- Individual participant dataSharing planned: Undecided
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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 Coronary Artery Disease and Atrial Fibrillation, 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 2 inclusion and 14 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 15 Sep 2022. 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?
Anticoagulation level (time frame: 4 - 12 hours). 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 NCT05541757, 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 15 Sep 2022.