Safety of Argatroban Infusion in Conduction Disturbances

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 18, 2017

Primary Completion Date

May 6, 2021

Study Completion Date

May 6, 2021

Conditions
Stable Coronary Artery Disease (CAD)Unstable Angina (Troponin Negative)
Interventions
DRUG

Argatroban

"Patients received an intravenous (i.v.) bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure. ACT was checked 5 minutes after bolus dose.~If ACT remained below the target of 300 s, the patient received an additional i.v. bolus injection of 150 μg/kg and the infusion dose was raised up to 30 μg/kg/min.~In cases ACT \> 450 s, the infusion was reduced to 15 μg/kg/min and the value was checked again after 5 minutes.~As soon as the target ACT (between 300 s and 450 s) was reached, infusion dose remained unchanged during the PCI procedure.~Depending on clinical relevancy further ACT assessments were possible."

Trial Locations (2)

36199

Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg, Rotenburg an der Fulda

60590

University Hospital Frankfurt, Frankfurt am Main

Sponsors
All Listed Sponsors
lead

Mitsubishi Tanabe Pharma GmbH

INDUSTRY