Heart rate control during a MultiSlice Computed Tomography Coronary Angiography (MST CA) for the evaluation of Coronary Artery Disease MedDRA version: 11.0 Level: LLT Classification code 10060804 Term:
Conditions
Interventions
Product Name: S 16257
Product Code: S 16257
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S 16257
Concentration unit: mg/ml
Sponsors
Institut de Recherches Internationales Servier (I.R.I.S)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Planned to undergo a scheduled MSCT CA for the evaluation of suspected or known CAD, - Not eligible for intravenous beta-blockers, - Electrocardiographic documentation of sinus rhythm and a stable heart rate, greater or equal to 70 bpm, - Able to perform a 20 seconds breath-hold, 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: - Current unstable clinical condition - NYHA functional classification IV - Scheduled coronary revascularisation, - Permanent atrial fibrillation or flutter, - Severe obstructive valvular disease, - Congenital heart disease, - Implanted pacemaker with atrial or ventricular permanent pacing, - Sick sinus syndrome or sinoatrial block, - 2nd or 3rd degree atrio-ventricular block, - History of recurrent episodes of sustained ventricular arrhythmia unless an implantable cardioverter defibrillator (ICD) is present, - Family history of long QT syndrome, congenital long QT symdrome, or treated with QT prolonging products, - Severe or uncontrolled hypertension, - Severe hypotension or symptomatic hypotension, - Suspicion of aortic dissection or thoracic aortic aneurysm, - Suspicion of pulmonary embolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients achieving heart rate control (i.e., a HR below or equal to 65 bpm) with intravenous ivabradine versus placebo at the time of initiation of image acquisition during a MSCT CA procedure;Main Objective: The primary objective of this study is to demonstrate that during a planned Multislice Computed Tomography Coronary Angiography (MSCT CA) for the evaluation of Coronary Artery Disease, ivabradine administered intravenously is superior to placebo in achieving heart rate control in patients not eligible for intravenous beta-blockers.;Secondary Objective: The secondary objectives are to assess versus placebo during the Multislice Computed Tomography Coronary Angiography (MSCT CA) for the evaluation of Coronary Artery Disease: (a) the safety of intravenous ivabradine, and (b) the procedural convenience of the use of intravenous ivabradine. | — |
Countries
Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
Outcome results
None listed