Rivaroxaban - Percutaneous Coronary Intervention

Completed

• Conditions: Coronary Artery Disease; Atrial Fibrillation
• Interventions: Drug: In vitro heparin

• Registration Number: NCT05541757
• Lead Sponsor: Bursa Postgraduate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Anticoagulation level	4 - 12 hours	anti-factor Xa

Trial Locations

Locations (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi; 🇹🇷 Bursa, Turkey