At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SAICoDis - Safety of Argatroban Infusion in Conduction Disturbances. A Prospective, Open, Multicenter Safety Study to Investigate Conduction Disturbances in Patients Receiving Argatroban Therapy.
In Brief
A Phase 4 clinical trial evaluating Argatroban for Stable Coronary Artery Disease (CAD) and Unstable Angina (Troponin Negative). Completed, enrolled 50 participants across 2 sites.
Detailed Summary
To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)
Study Details
Timeline
Interventions
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.