NCT05740371

Safety of Argatroban Infusion in Conduction Disturbances

SAICoDis - Safety of Argatroban Infusion in Conduction Disturbances. A Prospective, Open, Multicenter Safety Study to Investigate Conduction Disturbances in Patients Receiving Argatroban Therapy.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tanabe Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)

Detailed description

Primary objective: To determine change of corrected QT interval (QTc) during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI). Secondary objectives: * Determination of the QTc interval after sufficient wash-out period by ECG-3 which needed to be performed \> 8 but ≤ 28 hours after termination of prolonged argatroban infusion. * Investigation of dependence of QTc interval on gender and applied doses. * Determination of coagulation status during argatroban therapy. * Assessment of safety-related events within the scope of anticoagulation with argatroban, for example bleeding events or thromboembolic events.

Conditions

• Stable Coronary Artery Disease (CAD)
• Unstable Angina (Troponin Negative)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-18
• Primary completion: 2021-05-06
• Completion: 2021-05-06
• First posted: 2023-02-23
• Last updated: 2025-12-30
• Results posted: 2024-03-18

Locations

2 sites across 1 country: Germany