Condition category
Circulatory System
Date applied
07/11/2008
Date assigned
11/12/2008
Last edited
15/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jeroen Bax

ORCID ID

Contact details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26088378

Publication citations

Additional files

Editorial Notes

15/03/2016: Publication reference added.