Rivaroxaban - Percutaneous Coronary Intervention
In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients
1 other identifier
observational
30
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2021
1 active site
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, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedSeptember 15, 2022
September 1, 2022
1 year
September 13, 2022
September 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Anticoagulation level
anti-factor Xa
4 - 12 hours
Study Arms (2)
control group
five healthy adults
Study group
Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban
Interventions
Eligibility Criteria
patients with persistent or permanent AF had been using rivaroxaban 20 mg daily for at least one month
You may qualify if:
- patients using the direct oral factor Xa inhibitor rivaroxaban
- Atrial fibrillation
You may not qualify if:
- malignancy,
- coagulopathy,
- heart valve disease,
- active infection,
- chronic systemic or inflammatory disease,
- recent ACS or elective PCI,
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 37209152DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
September 13, 2022
First Posted
September 15, 2022
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
September 15, 2022
Record last verified: 2022-09