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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05740371
Study type Interventional
Source Mitsubishi Tanabe Pharma GmbH
Contact
Status Completed
Phase Phase 4
Start date April 18, 2017
Completion date May 6, 2021