Safety of Argatroban Infusion in Conduction Disturbances

Exclusion Criteria

• •Patient was indicated for highly complex 3-vessel intervention.
• •The female patient was pregnant (exclusion by routine urine test) or was nursing during therapy period.
• •Patients who were currently participating in another clinical trial or patients who participated in another clinical trial during the last 3 months prior to study start (date of treatment visit).
• •History of drug, alcohol or chemical abuse within 6 months prior to study start.
• •Planned surgical intervention other than study procedure within 7 days after study start.
• •Any condition, which contraindicated the use of argatroban, or endangered the patient if he/she participated in this study.
• •Factors influencing QTc interval:
• •Marked baseline prolongation of QTc interval (repeated demonstration of a QTc interval \> 450 ms at baseline ECG).
• •A history of risk factors of Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
• •Known intraventricular conduction disturbance.
• •Bradycardia: heart rate \< 45 min-1.
• •Electrolyte level outside normal range (according to laboratory's reference values).
• •The use of concomitant medications that interfered with the QTc interval.
• •Intake of digitalis within the last 2 weeks before study start.
• •Acute myocardial infarction or troponin-positive unstable angina.
• •Factors inhibiting use of argatroban in this study:
• •Intolerance to ingredients of Argatra® (sorbitol).
• •Known cirrhosis, hepatitis, clinically significant hepatic disorder at study start and/or history of clinically relevant hepatic disorder.
• •Current hepatic disorder indicated by laboratory liver profile at screening: Bilirubin, AST/SGOT, ALT/SGPT, gammaGT \> 3.0 times upper limit of the normal (ULN).
• •Renal insufficiency indicated by laboratory renal profile at study start: GFR \< 35 ml/min.
• •Uncontrolled hypertension (defined as blood pressure \>180/120 mmHg).
• •If any form of heparin was taken prior to study start and aPTT ≥ 35 s.
• •Intake of direct oral anticoagulants (DOAC) within 1 month prior to study start.
• •If anticoagulants of type of vitamin K antagonists (VKA) were taken prior to study start and INR \>1.2.
• •Platelet count \<125 x 109/l.
• •Documented coagulation disorder or bleeding diathesis.
• •Uncontrolled haemorrhage within the past 3 months.
• •Uncontrolled peptic ulcer disease or gastrointestinal bleeding within the past 3 months.
• •Cerebral aneurysm.
• •Haemorrhagic stroke or ischaemic stroke in the past 6 months.