Coronary Artery Disease patients presenting a low cardiac output syndrome following a planned coronary artery bypass graft and requiring a positive inotropic treatment with dobutamine administered as first line inotropic therapy. MedDRA version: 12.1 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft MedDRA version: 12.1 Level: PT Classification code 10024899 Term: Low cardiac output syndrome
Conditions
Interventions
Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S 16257
Concentration unit: mg/ml mi
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female of non childbearing potential, - Aged >= 18 years and = 20% >= 40%, documented by a trans-thoracic echocardiography within 1 month prior to the study enrolment, - HR >= 100 bpm after initiation of dobutamine infusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient with a clinically significant heart disease other than coronary heart disease - History of recurrent episodes of ventricular arrhythmia - History of permanent complete arrhythmia due to atrial fibrillation, flutter pacemaker or cardioverter-defibrillator implantation, - History of atrioventricular block of 2nd or 3rd degree, - Trifascicular block and PR > 240 msec, - Symptomatic hypotension or hypotension with SBP < 85 mmHg, - Severe or uncontrolled hypertension - LCOS occuring after a septic shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ivabradine administered by intravenous route in Coronary Artery Disease patients presenting a Low Cardiac Output Syndrome following a planned coronary artery bypass graft and requiring a positive inotropic treatment with dobutamine administered as first line inotropic therapy.;Secondary Objective: - To confirm that the efficacy of the inotropic treatment on haemodynamics is not altered when associated with ivabradine, - To optimize the inotropic treatment by reducing the related induced excessive tachycardia, - To evaluate the effect of ivabradine versus placebo on the reduction of early cardiovascular events, - To compare the safety profile of ivabradine to placebo.;Primary end point(s): The number and percentage of patients responders i.e. patients whose heart rate is within the range of 80 to 90 bpm: - for at least 30 minutes during ivabradine/placebo infusion - and/or allowing an increase of the inotropic treatment with dobutamine. | — |
Countries
France
Outcome results
None listed