Effects of a 10 or 15 mg single intravenous bolus of ivabradine versus placebo on heart rate control during a multislice computed tomography coronary angiography for the evaluation of coronary artery disease. A randomised, double blind, international, multicenter study.

Phase 1

Active, not recruiting

• Conditions: 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: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-006793-28-GB
• Lead Sponsor: Institut de Recherches Internationales Servier (I.R.I.S)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-17
• Study Completion: 2009-09-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 330

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

­- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. ;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