Rivaroxaban - Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541757
• Other study ID #: BYIEAH4
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2022
• Source: Bursa Postgraduate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease

Intervention

Drug:
• In vitro heparin
In vitro heparin and in vitro LMWH

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anticoagulation level	anti-factor Xa	4 - 12 hours