Conditions: Stable Coronary Artery Disease (CAD) Unstable Angina (Troponin Negative)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None

Interventions: intervention 1: Argatroban
Intervention descriptions: intervention 1: 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.

Protocol document:
Prot_000.pdf: 



































































































SAP_001.pdf: