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Rivaroxaban - Percutaneous Coronary Intervention

B

Bursa Postgraduate Hospital

Status

Completed

Conditions

Coronary Artery Disease
Atrial Fibrillation

Treatments

Drug: In vitro heparin

Study type

Observational

Funder types

Other

Identifiers

NCT05541757
BYİEAH4

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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).

Trial design

30 participants in 2 patient groups

control group
Description:
five healthy adults
Treatment:
Drug: In vitro heparin
Study group
Description:
Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban
Treatment:
Drug: In vitro heparin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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