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Rivaroxaban - Percutaneous Coronary Intervention

In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05541757
Enrollment
30
Registered
2022-09-15
Start date
2021-01-01
Completion date
2022-03-01
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Coronary Artery Disease

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.

Interventions

DRUGIn vitro heparin

In vitro heparin and in vitro LMWH

Sponsors

Bursa Postgraduate Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 74 Years

Inclusion criteria

* patients using the direct oral factor Xa inhibitor rivaroxaban * Atrial fibrillation

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Anticoagulation level4 - 12 hoursanti-factor Xa

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026