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.

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: 11.0Level: LLTClassification code 10060804Term: <Manually entered code. Term in E.1.1>

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-17
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• 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