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
Scientific
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure | 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 study start date | 01/10/2008 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- 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
2333 ZA
Netherlands
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"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 share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
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.
