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
EudraCT/CTIS number 2007-006793-28
Secondary identifying numbers CL3-16257-078
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

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects 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 objectivesEvaluate 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) studiedMultislice computed tomography coronary angiography for the evaluation of coronary artery disease
Intervention10 or 15 mg single intravenous bolus administration of ivabradine/placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Ivabradine
Primary outcome measureHeart rate control <=65 bpm at the time of initiation of image acquisition during MST CA procedure.
Secondary outcome measures1. Safety of intravenous ivabradine during and after MSCT CA procedure until 3 days after ivabradine administration
2. Pharmacokinetics
Overall study start date01/10/2008
Completion date31/05/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants330
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2008
Date of final enrolment31/05/2010

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

Study participating centre

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website http://www.servier.com/
ROR logo "ROR" https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication 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 planThe 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?
Basic results No No
Results article results 01/07/2015 Yes No

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.