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.

Institut de Recherches Internationales Servier (I.R.I.S)0 个研究点目标入组 330 人开始时间: 2008年7月2日最近更新: 2013年4月29日

适应症

试验速览

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•- Male or female patients,
•- Aged 18 years (or having reached majority if the legal age of majority in the country is over 18 years) or more when the informed consent is signed.
•- 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
•- HR eligibility: The ‘HR eligibility criterion’ is met only if the last two consecutive baseline HR measurements at 3 minutes interval document a HR ³ 70 bpm and the difference between the last two baseline measurements is < 5%
•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

•- 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,
•- Women of childbearing potential.

发起方

Institut de Recherches Internationales Servier (I.R.I.S)