Additional identifiers
EudraCT number
2007-006793-28
ClinicalTrials.gov number
Protocol/serial number
CL3-16257-078
Study information
Scientific title
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, multi-centre study
Acronym
Study hypothesis
Evaluate the effect of a 10 or 15 mg single intravenous bolus of ivabradine versus placebo on heart rate control during a multislice computed tomography coronary angiography (MSCT-CA) for the evaluation of coronary artery disease.
Ethics approval
Ethics Committee for Protection of Human Subjects (CPP) Ile de France IX Créteil, France, 03/07/2008
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multislice computed tomography coronary angiography for the evaluation of coronary artery disease
Intervention
10 or 15 mg single intravenous bolus administration of ivabradine/placebo.
Intervention type
Drug
Phase
Phase IV
Drug names
Ivabradine
Primary outcome measures
Heart rate control <=65 bpm at the time of initiation of image acquisition during MST CA procedure.
Secondary outcome measures
1. Safety of intravenous ivabradine during and after MSCT CA procedure until 3 days after ivabradine administration
2. Pharmacokinetics
Overall trial start date
01/10/2008
Overall trial end date
31/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female patients of non-childbearing potential >=18 years
2. Planned to undergo a scheduled multislice computed tomography coronary angiography
3. Not eligible for intravenous beta-blockers
4. Electrocardiographic documentation of sinus rhythm and a stable heart rate >=70 bpm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
1. Current unstable clinical condition
2. New York Heart Association (NYHA) functional classification IV
3. Scheduled coronary revascularisation
4. Permanent atrial fibrillation or flutter
5. Severe obstructive valvular disease, congenital heart disease
6. Implanted pacemaker with atrial or ventricular permanent pacing
7. Sick sinus syndrome or sinoatrial block
8. Second or third degree atrio-ventricular block
Recruitment start date
01/10/2008
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Australia, Belgium, Brazil, Bulgaria, Denmark, France, Germany, Hungary, Italy, Korea, South, Netherlands, Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, United Kingdom
Trial participating centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-16257-078_synopsis_report.pdf
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26088378