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

ISRCTN	ISRCTN67252793
DOI	https://doi.org/10.1186/ISRCTN67252793
Clinical Trials Information System (CTIS)	2007-006793-28
Protocol serial number	CL3-16257-078
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 07/11/2008
Registration date: 11/12/2008
Last edited: 28/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Jeroen Bax
Scientific

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics Committee for Protection of Human Subjects (CPP) Ile de France IX Créteil, France, 03/07/2008
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ivabradine
Primary outcome measure(s)	Heart rate control <=65 bpm at the time of initiation of image acquisition during MST CA procedure.
Key secondary outcome measure(s)	1. Safety of intravenous ivabradine during and after MSCT CA procedure until 3 days after ivabradine administration 2. Pharmacokinetics
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	330
Key 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
Key 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
Date of first enrolment	01/10/2008
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

United Kingdom
Australia
Belgium
Brazil
Bulgaria
Denmark
France
Germany
Hungary
Italy
Korea, South
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
South Africa
Spain
Taiwan

Study participating centre

Albinusdreef 2

Leiden
2333 ZA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
14/12/2017: results summary added.
15/03/2016: Publication reference added.